Download PLR Content Directory Curaçao: September 2016

Friday, September 30, 2016

Noebra

Noebra may be available in the countries listed below.

Ingredient matches for Noebra

Choline Alfoscerate

Choline Alfoscerate is reported as an ingredient of Noebra in the following countries:

Greece

International Drug Name Search

Phenabid DM Sustained-Release Tablets

Pronunciation: klor-fen-EER-a-meen/dex-troe-meth-OR-fan/fen-ill-EF-rin
Generic Name: Chlorpheniramine/Dextromethorphan/Phenylephrine
Brand Name: Phenabid DM

Phenabid DM Sustained-Release Tablets are used for:

Relieving sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Phenabid DM Sustained-Release Tablets are a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking histamine, which helps reduce symptoms, such as watery eyes and sneezing, while the cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Phenabid DM Sustained-Release Tablets if:

you are allergic to any ingredient in Phenabid DM Sustained-Release Tablets

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

you are unable to urinate or are having an asthma attack

you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Phenabid DM Sustained-Release Tablets:

Some medical conditions may interact with Phenabid DM Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, intestines, or bladder; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid

if you have a history of asthma, chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Phenabid DM Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone , indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Phenabid DM Sustained-Release Tablets may be increased

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Phenabid DM Sustained-Release Tablets

Guanadrel, guanethidine, methyldopa, mecamylamine, or reserpine because their effectiveness may be decreased by Phenabid DM Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenabid DM Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Phenabid DM Sustained-Release Tablets:

Use Phenabid DM Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Phenabid DM Sustained-Release Tablets may be taken with or without food.

Swallow Phenabid DM Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.

If you miss a dose of Phenabid DM Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenabid DM Sustained-Release Tablets.

Important safety information:

Phenabid DM Sustained-Release Tablets may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Phenabid DM Sustained-Release Tablets. Using Phenabid DM Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Do not take diet or appetite control medicines while you are taking Phenabid DM Sustained-Release Tablets without checking with your doctor.

Phenabid DM Sustained-Release Tablets contains chlorpheniramine, dextromethorphan, and phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains chlorpheniramine, dextromethorphan, or phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.

Do NOT exceed the recommended dose or take Phenabid DM Sustained-Release Tablets for longer than prescribed without checking with your doctor.

If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

Phenabid DM Sustained-Release Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Phenabid DM Sustained-Release Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

If you are scheduled for allergy skin testing, do not take Phenabid DM Sustained-Release Tablets for several days before the test because it may decrease your response to the skin tests.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Phenabid DM Sustained-Release Tablets.

Use Phenabid DM Sustained-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects.

Caution is advised when using Phenabid DM Sustained-Release Tablets in CHILDREN because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Phenabid DM Sustained-Release Tablets, discuss with your doctor the benefits and risks of using Phenabid DM Sustained-Release Tablets during pregnancy. It is unknown if Phenabid DM Sustained-Release Tablets are excreted in breast milk. Do not breast-feed while taking Phenabid DM Sustained-Release Tablets.

Possible side effects of Phenabid DM Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Phenabid DM side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; severe dizziness, lightheadedness, or headache; severe drowsiness; seizures; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Phenabid DM Sustained-Release Tablets:

Store Phenabid DM Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenabid DM Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Phenabid DM Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Phenabid DM Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Phenabid DM Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Phenabid DM resources

Phenabid DM Side Effects (in more detail)
Phenabid DM Use in Pregnancy & Breastfeeding
Phenabid DM Drug Interactions
Phenabid DM Support Group
0 Reviews for Phenabid DM - Add your own review/rating

Compare Phenabid DM with other medications

Cough and Nasal Congestion

Asclera

Generic Name: laureth-9

Dosage Form: injection, solution
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE

Asclera(R) (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins less than or equal to 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.

2 DOSAGE AND ADMINISTRATION

For intravenous use only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter is seen or if the contents of the vial are discolored or of the vial is damaged in any way.

For spider veins (varicose veins less than or equal to 1 mm in diameter), use Asclera 0.5%. For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera 1%. Use 0.1 to 0.3 mL per injection and no more than 10 mL per session.

Use a syringe (glass or plastic) with a fine needle (typically, 26 or 30 gauge). Insert the needle tangentially into the vein and inject the solution slowly while the needle is still in the vein. Apply only gentle pressure during injection to prevent vein rupture. After the needle has been removed and the injection site has been covered, apply compression in the form of a stocking or bandage. After the treatment session, encourage the patient to walk for 15 to 20 minutes. Keep the patient under observation to detect any anaphylactic or allergic reaction (see Warnings and Precautions [5]).

Maintain compression for 2 to 3 days after treatment of spider veins and 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.

Repeat treatments may be necessary if the extent of the varicose veins require more than 10 mL. These treatments should be separated by 1 to 2 weeks.

Small intravaricose blood clots (thrombi) that develop may be removed by stab incision and thrombus expression (microthrombectomy).

3 DOSAGE FORMS AND STRENGTHS

Asclera is available as a 0.5% and 1% solution in 2 mL glass ampules.

4 CONTRAINDICATION

Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylaxis

Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some them fatal. Severe reactions are more frequent with use of larger volumes (greater than 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately.

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, care should be taken in intravenous needle placement and the smallest effective volume at each injection site should be used.

After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction (see Dosage and Administration [2]).

5.2 Accidental Intra-arterial Injection

Intra-arterial injection can cause severe necrosis, ischemia or gangrene. If this occurs consult a vascular surgeon immediately.

5.3 Inadvertent Perivascular Injection

Inadvertent perivascular injection of Asclera can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected.

6 ADVERSE REACTIONS

6.1 Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 5 controlled randomized clinical trials, Asclera has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo. Patients were 18 to 70 years old. The patient population was predominantly female and consisted of Caucasian and Asian patients.

Table 1 shows adverse events more common with Asclera or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo-controlled EASI study (see Clinical Studies [14]). All of these were injection site reactions and most were mild.

Table 1: Adverse Reactions in EASI-study

	Asclera (180 patients)	STS 1% (105 patients)	Placebo (53 patients)
Injection site haematoma	42%	65%	19%
Injection site irritation	41%	73%	30%
Injection site discoloration	38%	74%	4%
Injection site pain	24%	31%	9%
Injection site pruritus	19%	27%	4%
Injection site warmth	16%	21%	6%
Neovascularisation	8%	20%	4%
Injection site thrombosis	6%	1%	0%

Ultrasound examinations at one week (plus or minus 3 days) and 12 weeks (plus or minus 2 weeks) after treatment did not reveal deep vein thrombosis in any treatment group.

6.2 Post-marketing Safety Experience

The following adverse reactions have been reported during the use of polidocanol in world-wide experience; in some of these cases these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma

Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness

Cardiac disorders: Cardiac arrest, palpitations

Vascular disorders: Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis

Respiratory, thoracic and mediastinal disorders: Dyspnea

General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush

Injury, poisoning and procedural complications: Nerve injury 7 DRUG INTERACTIONS

No drug-drug interactions have been studied with Asclera.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose. This effect may have been secondary to maternal toxicity. There are no adequate and well controlled studies in pregnant women. Asclera should not be used during pregnancy.

Animal Studies

Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration. Polidocanol induced maternal and fetal toxicity in rabbits, including reduced mean fetal weight and reduced fetal survival, when administered during gestation days 6-20 at doses 4 and 10 mg/kg, but it did not cause skeletal or visceral abnormalities. No adverse maternal or fetal effects were observed in rabbits at a dose of 2 mg/kg. No evidence of teratogenicity or fetal toxicity was observed in rats dosed during gestation days 6-17 with doses up to 10 mg/kg. Polidocanol did not affect the ability of rats to deliver and rear pups when administered intermittently by intravenous injection from gestation day 17 to post-partum day 21 at doses up to 10 mg/kg.

Human Studies

There are no adequate and well-controlled studies on the use of Asclera in pregnant women.

8.2 Labor and Delivery

The effects of Asclera on labor and delivery in pregnant women are unknown.

8.3 Nursing Mothers

It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of Asclera in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 10 OVERDOSAGE

Overdose may result in a higher incidence of localized reactions such as necrosis.

11 DESCRIPTION

Asclera is a sterile, nonpyrogenic, and colorless to faintly greenish-yellow solution of polidocanol for intravenous use as a sclerosing agent.

The active ingredient, polidocanol is a non-ionic detergent, consisting of two components, a polar hydrophillic (dodecyl alcohol) and an apolar hydrophobic (polyethylene oxide) chain. Polidocanol has the following structural formula:

C12H25(OCH2CH2)nOH Polyethylene glycol monododecyl ether

Mean extent of polymerization (n): Approximately 9

Mean molecular weight: Approximately 600

Each mL contains 5 mg (0.5%) or 10 mg (1.0%) polidocanol in water for injection with 5% (v/v) ethanol at pH 6.5-8.0; disodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate are added for pH adjustment.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The active ingredient of Asclera is polidocanol.

Polidocanol is a sclerosing agent that locally damages the endothelium of blood vessels. When injected intravenously, polidocanol induces endothelial damage. Platelets then aggregate at the site of damage and attach to the venous wall. Eventually, a dense network of platelets, cellular debris, and fibrin occludes the vessel. Finally, the occluded vein is replaced with connective fibrous tissue.

12.2 Pharmacodynamics

Polidocanol has a concentration and volume dependent damaging effect on the endothelium of blood vessels.

12.3 Pharmacokinetics

During the major effectiveness study (EASI-trial), scheduled blood samples were taken from a sub-group of 22 patients to measure plasma levels of polidocanol after Asclera treatment of spider and reticular veins. Low systemic blood levels of polidocanol were seen in some patients.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate carcinogenic potential have not been conducted with polidocanol. Poliodocanol was negative in bacterial reverse mutation assays in Salmonella and E. Coli, and in micronucleus assay conducted in mice. Polidocanol induced numerical chromosonal aberrations in cultured newborn Chinese hamster lung fibroblasts in the absence of metabolic activation.

Polidocanol did not affect reproductive performance (fertility) of rats when administered intermittently at dosages up to 10 mg/kg (approximately equal to the maximum human dose on the basis of body surface area). 14 CLINICAL STUDIES

Asclera was evaluated in a multicenter, randomized, double-blind, placebo and comparator controlled trial (EASI-study) in patients with spider or reticular varicose veins. A total of 338 patients were treated with Asclera [0.5% for spider veins (n=94), 1% for reticular veins (n=86)], sodium tetradecyl sulfate (STS) 1% (n=105), or placebo (0.9% isotonic saline solution) (n=53) for either spider or reticular veins. Patients were predominantly female, ranging in age from 19 to 70 years old. All of them received an intravenous injection in the first treatment session; repeat injections were given three to six weeks later if the previous injection was evaluated as unsuccessful (defined as 1, 2, or 3 on a 5-point scale, see below). Patients returned at 12 and 26 weeks after the last injection for final assessments.

The primary effectiveness endpoint was improvement of veins judges by a blinded panel. Digital images of the selected treatment area were taken prior to injection, compared with those taken at 12 weeks post-treatment, and rated on a 5-point scale (1 = worse than before, 2 = same as before, 3 = moderate improvement, 4 = good improvement, 5 = complete treatment success_; results are shown in Table 2.

Table 2: Improvement of veins in digital photographs after 12 weeks and 26

Treatment Group	Polidocanol (n=155)	STS (n=105)	Placebo (n=53)
Digital Photograph Scores at 12 Weeks
Mean + SD	4.5* + 0.7	4.5* + 0.7	2.2 + 0.7
Digital Photograph Scores at 26 Weeks
Mean + SD	4.5* + 0.7	4.5* + 0.8	2.2 + 0.7

*p less than 0.0001 compared to placebo (Wilcoxon-Mann-Whitney test)

The secondary efficacy criterion was the rate of treatment success, pre-defined as a score of 4 or 5 with patients scoring 1, 2, or 3 considered treatment failures; results are shown in Table 3.

Table 3: Treatment success rates at 12 weeks and 26 weeks

Treatment success?*	Polidocanol (n=155)	STS (n=105)	Placebo (n=53)
At 12 weeks (Visit 4)
Yes	95%**	92%**	8%
No	5%	8%	92%
Missing	0.6%	0%	0%
At 26 weeks (Visit 5)
Yes	95%**	91%**	6%
No	5%	9%	94%

*Treatment success: Yes = Grade 4 to 5, no = Grade 1 to 3; derived from median of evaluation; **p less than 0.0001 compared to placebo.

At 12 and 26 weeks, patients' judgement of the results was assessed by showing them the digital images of their treatment area taken at baseline and asking them to rate their satisfaction with their treatment using a verbal rating scale (1 = very unsatisfied, 2 = somewhat satisfied, 3 = slightly satisfied, 4 = satisfied, and 5 = very satisfied); results are shown in Table 4.

Table 4: Patient satisfaction after 12 weeks and 26 weeks

	Polidocanol (n=155)	STS (n=105)	Placebo (n=53)
Patient satisfaction with treatment after 12 weeks (Visit 4)
Satisfied or very satisfied	87%*	64%	14%
Patient satisfaction with treatment after 26 weeks (Visit 5)
Satisfied or very satisfied	84%*	63%	16%

*p less than 0.0001 compared to STS and placebo

16 HOW SUPPLIED/STORAGE AND HANDLING

Asclera is supplied in single use, preservative free ampules in the following packages:

NDC 46783-121-52 Five 0.5% ampules (2 mL)

NDC 46783-221-52 Five 1.0% ampules (2 mL)

Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years.

Store at 15-30 degrees Celsius; (59-86 degrees Fahrenheit).

17 PATIENT COUNSELING INFORMATION

Advise patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime. Compression stockings or support hose should be thigh or knee high depending on the area treated in order to provide adequate coverage.

Advise patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days.

For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna.

Asclera
laureth-9 injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	46783-221
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LAURETH-9 (LAURETH-9)	LAURETH-9	0.01000 g in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL	0.04200 g in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC	0.00085 g in 1 mL
SODIUM PHOSPHATE, DIBASIC	0.00240 g in 1 mL
WATER	0.93875 g in 1 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	46783-221-52	2 mL In 1 AMPULE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021201	06/01/2010

Asclera
laureth-9 injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	46783-121
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LAURETH-9 (LAURETH-9)	LAURETH-9	0.00500 g in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL	0.04200 g in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC	0.00043 g in 1 mL
SODIUM PHOSPHATE, DIBASIC	0.00120 g in 1 mL
WATER	0.94437 g in 1 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	46783-121-52	2 mL In 1 AMPULE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021201	06/01/2010

Labeler - Merz Aesthetics, Inc. (137113929)

Revised: 01/2011Merz Aesthetics, Inc.

More Asclera resources

Asclera Side Effects (in more detail)
Asclera Dosage
Asclera Use in Pregnancy & Breastfeeding
Asclera Support Group
0 Reviews for Asclera - Add your own review/rating

Asclera Consumer Overview

Compare Asclera with other medications

Varicose Veins

Thursday, September 29, 2016

EnacoMi

EnacoMi may be available in the countries listed below.

Ingredient matches for EnacoMi

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of EnacoMi in the following countries:

Germany

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of EnacoMi in the following countries:

Germany

International Drug Name Search

Tylenol Cold Multi-Symptom Daytime Liquid

Pronunciation: a-SEET-a-MIN-oh-fen/DEX-troe-meth-OR-fan/gwye-FEN-e-sin/FEN-il-EF-rin
Generic Name: Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine
Brand Name: Tylenol Cold Multi-Symptom Daytime

Tylenol Cold Multi-Symptom Daytime Liquid is used for:

Relieving pain, congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Tylenol Cold Multi-Symptom Daytime Liquid is an analgesic, decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The analgesic and cough suppressant works in the brain to decrease pain and to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tylenol Cold Multi-Symptom Daytime Liquid if:

you are allergic to any ingredient in Tylenol Cold Multi-Symptom Daytime Liquid

you have severe high blood pressure, rapid heartbeat, severe heart blood vessel disease, or other severe heart problems

you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol Cold Multi-Symptom Daytime Liquid:

Some medical conditions may interact with Tylenol Cold Multi-Symptom Daytime Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of glaucoma, an enlarged prostate or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, liver problems, or severe kidney problems, or if you drink 3 or more drinks with alcohol per day

if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

if you smoke or have a history of addiction to alcohol

Some MEDICINES MAY INTERACT with Tylenol Cold Multi-Symptom Daytime Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of Tylenol Cold Multi-Symptom Daytime Liquid's side effects may be increased

Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased

Bromocriptine because the risk of its side effects may be increased by Tylenol Cold Multi-Symptom Daytime Liquid

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Tylenol Cold Multi-Symptom Daytime Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Cold Multi-Symptom Daytime Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol Cold Multi-Symptom Daytime Liquid:

Use Tylenol Cold Multi-Symptom Daytime Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Tylenol Cold Multi-Symptom Daytime Liquid by mouth with or without food.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

Drink plenty of water while taking Tylenol Cold Multi-Symptom Daytime Liquid.

If you miss a dose of Tylenol Cold Multi-Symptom Daytime Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Cold Multi-Symptom Daytime Liquid.

Important safety information:

Tylenol Cold Multi-Symptom Daytime Liquid may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tylenol Cold Multi-Symptom Daytime Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not take appetite suppressants while you use Tylenol Cold Multi-Symptom Daytime Liquid unless your doctor tells you otherwise.

Tylenol Cold Multi-Symptom Daytime Liquid contains acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. Before you start any new medicine, check the label to see if it has any of these medicines or similar medicines in it. If it does or if you are not sure, check with your doctor or pharmacist.

Do not use Tylenol Cold Multi-Symptom Daytime Liquid for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 7 days or if they get worse, check with your doctor.

Tylenol Cold Multi-Symptom Daytime Liquid may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol Cold Multi-Symptom Daytime Liquid. Talk to your doctor before you take Tylenol Cold Multi-Symptom Daytime Liquid or other fever reducers if you drink more than 3 drinks with alcohol per day.

Tylenol Cold Multi-Symptom Daytime Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tylenol Cold Multi-Symptom Daytime Liquid.

Tell your doctor or dentist that you take Tylenol Cold Multi-Symptom Daytime Liquid before you receive any medical or dental care, emergency care, or surgery.

Use Tylenol Cold Multi-Symptom Daytime Liquid with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Tylenol Cold Multi-Symptom Daytime Liquid in CHILDREN; they may be more sensitive to its effects.

Different brands of Tylenol Cold Multi-Symptom Daytime Liquid may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

PREGNANCY and BREAST-FEEDING: It is not known if Tylenol Cold Multi-Symptom Daytime Liquid can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol Cold Multi-Symptom Daytime Liquid while you are pregnant. It is not known if Tylenol Cold Multi-Symptom Daytime Liquid is found in breast milk. Do not breast-feed while taking Tylenol Cold Multi-Symptom Daytime Liquid.

Possible side effects of Tylenol Cold Multi-Symptom Daytime Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

See also: Tylenol Cold Multi-Symptom Daytime side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Tylenol Cold Multi-Symptom Daytime Liquid:

Store Tylenol Cold Multi-Symptom Daytime Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Cold Multi-Symptom Daytime Liquid out of the reach of children and away from pets.

General information:

If you have any questions about Tylenol Cold Multi-Symptom Daytime Liquid, please talk with your doctor, pharmacist, or other health care provider.

Tylenol Cold Multi-Symptom Daytime Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tylenol Cold Multi-Symptom Daytime Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Tylenol Cold Multi-Symptom Daytime resources

Tylenol Cold Multi-Symptom Daytime Side Effects (in more detail)
Tylenol Cold Multi-Symptom Daytime Use in Pregnancy & Breastfeeding
Tylenol Cold Multi-Symptom Daytime Drug Interactions
0 Reviews for Tylenol Cold Multi-Symptom Daytime - Add your own review/rating

Compare Tylenol Cold Multi-Symptom Daytime with other medications

Cold Symptoms
Influenza

Wednesday, September 28, 2016

altretamine

Generic Name: altretamine (all TREH tah mean)

Brand Names: Hexalen

What is altretamine?

Altretamine is a cancer (antineoplastic) medication. Altretamine interferes with the growth of cancer cells and slows their growth and spread in the body.

Altretamine is used to treat cancer of the ovaries.

Altretamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about altretamine?

Altretamine should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of altretamine including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); neurologic problems (mood disorders, altered consciousness, weakness, dizziness, vertigo); and others. Talk to your doctor about the possible side effects from treatment with altretamine.

What should I discuss with my healthcare provider before taking altretamine?

Before taking altretamine, tell your doctor if you have:

any nervous system (brain and nerves) problems; or

bone marrow problems.

You may not be able to take altretamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Altretamine is in the FDA pregnancy category D. This means that altretamine is known to cause birth defects in an unborn baby. Do not take altretamine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Contraceptive measures are recommended during treatment with altretamine. It is not known whether altretamine passes into breast milk. Do not take altretamine without first talking to your doctor if you are breast feeding a baby.

How should I take altretamine?

Take altretamine exactly as directed by your doctor. If you do not understand these instructions, as your doctor, nurse or pharmacist to explain them to you.

Your doctor will determine the correct amount and frequency of treatment with altretamine depending upon the cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Altretamine is usually taken four times a day, after meals and at bedtime.

Take each oral dose with a large glass of water.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with altretamine to monitor progress and side effects.

Store altretamine capsules at room temperature away from heat and moisture. Keep this product out of the reach of children.

See also: Altretamine dosage (in more detail)

What happens if I miss a dose?

Contact your doctor if you miss a dose of altretamine.

What happens if I overdose?

If for any reason an overdose of altretamine is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of an altretamine overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while taking altretamine?

Altretamine can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with altretamine. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Altretamine side effects

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);

decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);

pain, tremors, tingling, burning, or prickling in hands or feet;

mood changes;

severe drowsiness or loss of consciousness;

loss of coordination, weakness, dizziness, unsteadiness or falling; or

severe nausea or vomiting.

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience:

temporary hair loss;

itching or rash; or

mild to moderate nausea or vomiting.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Altretamine Dosing Information

Usual Adult Dose for Ovarian Cancer:

260 mg/m2/day administered either for 14 or 21 consecutive days in a 28 day cycle. The total daily dose should be given as 4 divided oral doses after meals and at bedtime.

Altretamine should be temporarily discontinued (for 14 days or longer) and subsequently restarted at 200 mg/m2/day for any of the following situations:

Gastrointestinal intolerance unresponsive to symptomatic measures;
White blood count Platelet count Progressive neurotoxicity.

If neurologic symptoms fail to stabilize on the reduced dose schedule, altretamine should be discontinued indefinitely.

What other drugs will affect altretamine?

Before taking altretamine, tell your doctor if you are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate). You may require a dosage adjustment or special monitoring during treatment if you are taking one of these medicines.

Before taking altretamine, tell your doctor if you are taking cimetidine (Tagamet, Tagamet HB). You may require a dosage adjustment or special monitoring during treatment.

Do not receive "live" vaccines during treatment with altretamine. Administration of a live vaccine may be dangerous during treatment with altretamine.

Drugs other than those listed here may also interact with altretamine. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with altretamine.

More altretamine resources

Altretamine Side Effects (in more detail)
Altretamine Dosage
Altretamine Use in Pregnancy & Breastfeeding
Altretamine Drug Interactions
Altretamine Support Group
0 Reviews for Altretamine - Add your own review/rating

altretamine Advanced Consumer (Micromedex) - Includes Dosage Information

Altretamine Professional Patient Advice (Wolters Kluwer)

Altretamine Monograph (AHFS DI)

Altretamine MedFacts Consumer Leaflet (Wolters Kluwer)

Hexalen Prescribing Information (FDA)

Compare altretamine with other medications

Ovarian Cancer

Where can I get more information?

Your pharmacist has additional information about altretamine written for health professionals that you may read.

See also: altretamine side effects (in more detail)

Herten

Herten may be available in the countries listed below.

Ingredient matches for Herten

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Herten in the following countries:

Spain

International Drug Name Search

Tuesday, September 27, 2016

Erythromycin Ethyl Succinate

Erythromycin Ethyl Succinate may be available in the countries listed below.

Ingredient matches for Erythromycin Ethyl Succinate

Erythromycin

Erythromycin Ethyl Succinate (BANM) is known as Erythromycin in the US.

International Drug Name Search

Glossary

BANM

British Approved Name (Modified)

Click for further information on drug naming conventions and International Nonproprietary Names.

Alerday

Alerday may be available in the countries listed below.

Ingredient matches for Alerday

Fexofenadine

Fexofenadine hydrochloride (a derivative of Fexofenadine) is reported as an ingredient of Alerday in the following countries:

Myanmar

International Drug Name Search

Unifungin

Unifungin may be available in the countries listed below.

Ingredient matches for Unifungin

Econazole

Econazole is reported as an ingredient of Unifungin in the following countries:

Greece

International Drug Name Search

Malival

Malival may be available in the countries listed below.

Ingredient matches for Malival

Indometacin

Indometacin is reported as an ingredient of Malival in the following countries:

Dominican Republic

El Salvador

Honduras

Mexico

International Drug Name Search

Aminocaproic Acid

Class: Hemostatics
VA Class: BL300
CAS Number: 60-32-2
Brands: Amicar

Introduction

A synthetic monoamino carboxylic acid that is an inhibitor of fibrinolysis.^b

Uses for Aminocaproic Acid

Bleeding Due to Elevated Fibrinolytic Activity

Treatment of excessive bleeding resulting from systemic hyperfibrinolysis and urinary fibrinolysis.^b In life-threatening situations, fresh whole blood, fibrinogen infusions, and other emergency measures also may be required.^b

Used in systemic hyperfibrinolysis associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; in carcinoma of the lung, prostate, cervix, or stomach; in abruptio placentae; and in hematologic disorders such as amegakaryocytic thrombocytopenia accompanying aplastic anemia (reduces the need for platelet transfusions).¹⁰⁸ ^b

Used in urinary fibrinolysis associated with complications of severe trauma, anoxia, and shock,^a and as manifested by surgical hematuria especially following prostatectomy and nephrectomy,^b or in nonsurgical hematuria accompanying polycystic or neoplastic disease of the GU tract.^b

Used in conjunction with heparin therapy in patients with acute promyelocytic leukemia†; initiate therapy when plasma α₂-antiplasmin (α₂-plasmin inhibitor) levels have decreased to <40% of normal levels.¹⁰⁷

Ocular Hemorrhage

Has been used effectively for the prevention of secondary ocular hemorrhage in patients with nonperforating traumatic hyphema†.¹⁰⁰ ¹⁰¹ ¹⁰² ¹⁰³ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ Designated an orphan drug by FDA for topical treatment of traumatic hyphema.¹¹⁹

Hereditary Hemorrhagic Telangiectasia

Has been used orally for the management of hereditary hemorrhagic telangiectasia†.¹¹²

Aminocaproic Acid Dosage and Administration

Administration

Administer orally or by IV infusion.^b

Oral Administration

Administer orally if the patient is able to take oral medication.^b

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.^b

Avoid rapid IV administration; hypotension, bradycardia, and/or arrhythmia may result.^b

Dilution

For the initial infusion (loading dose), add 4–5 g of aminocaproic acid (16–20 mL of the injection) to 250 mL of diluent.^b

For maintenance infusions, add 1 g of aminocaproic acid (4 mL of the injection) to 50 mL of diluent to provide a final concentration of approximately 20 mg/mL.^b

Rate of Administration

Initial infusion (loading dose): Infuse 4–5 g over 1 hour in adults.^b

Maintenance infusion: Infuse 1 g per hour in adults.^b

Dosage

Pediatric Patients

Bleeding Due to Elevated Fibrinolytic Activity†

Oral

100 mg/kg or 3 g/m² during the first hour, then 33.3 mg/kg per hour or 1 g/m² per hour (maximum 18 g/m² in 24 hours) has been used.^a Manufacturer states that safety and efficacy not established in pediatric patients.^b

IV

Initial infusion (loading dose): 100 mg/kg or 3 g/m² over 1 hour has been used.^a Manufacturer states that safety and efficacy not established in pediatric patients.^b

Maintenance infusion

Maintenance infusion: 33.3 mg/kg per hour or 1 g/m² per hour (maximum 18 g/m² in 24 hours) has been used.^a Manufacturer states that safety and efficacy not established in pediatric patients.^b

Adults

Bleeding Due to Elevated Fibrinolytic Activity

Oral

5 g during the first hour, then 1–1.25 g per hour for about 8 hours or until bleeding has been controlled.^a ^b

IV

Initial infusion (loading dose): 4–5 g over 1 hour.^b

Maintenance infusion: 1 g per hour for about 8 hours or until bleeding has been controlled.^b

Ocular Hemorrhage†

Oral

100 mg/kg (up to 5 g) every 4 hours, up to a maximum daily dosage of 30 g, for 5 days has been used;¹⁰⁰ ¹⁰¹ ¹⁰² ¹⁰³ lower daily dosages also may be effective.¹⁰²

Hereditary Hemorrhagic Telangiectasia†

Oral

1 or 1.5 g twice daily for 1–2 months, followed by 1–2 g daily.¹¹²

Prescribing Limits

Pediatric Patients

Bleeding Due to Elevated Fibrinolytic Activity†

Oral or IV

Maximum 18 g/m² in 24 hours.^a

Adults

Ocular Hemorrhage

Oral

Maximum 30 g daily.¹⁰⁰ ¹⁰¹ ¹⁰² ¹⁰³

Cautions for Aminocaproic Acid

Contraindications

Active intravascular clotting process.^b

When it is not clear whether hemorrhage is secondary to primary fibrinolysis or disseminated intravascular coagulation (DIC), the distinction must be made before aminocaproic acid is administered.^b Do not use without concomitant heparin therapy in patients with evidence of DIC.^b

Warnings/Precautions

Warnings

Urinary Tract Bleeding

Intrarenal obstruction via glomerular capillary thrombosis or clots in the renal pelvis and ureters reported in patients with upper urinary tract bleeding.^b The drug should not be used in patients with hematuria of upper urinary tract origin unless the potential benefits outweigh risks.^b

Musculoskeletal Effects

Skeletal muscle weakness with necrosis of muscle fiber reported with prolonged administration.^b Presentation may range from mild myalgias with weakness and fatigue to severe proximal myopathy with rhabdomyolysis, myoglobinuria, and renal failure; CK levels are elevated.^b Manifestations resolve with drug discontinuance but may recur if therapy is reinstated.^b

Monitor CK concentrations with long-term therapy.^b Discontinue drug if an increase in CK occurs.^b

If skeletal myopathy occurs, consider possibility of cardiac muscle damage.^b

Benzyl Alcohol in Neonates

Aminocaproic acid injection contains as a preservative benzyl alcohol, which has been associated with toxicity (fatalities) in neonates.^b (See Pediatric Precautions.)

General Precautions

Should be used only in acute, life-threatening situations^a involving hemorrhage resulting from hyperfibrinolysis that has been confirmed by laboratory studies.^b

Clot Formation

If aminocaproic acid is present, clots formed in vivo may not undergo spontaneous lysis as do normal clots because aminocaproic acid in the clot may inhibit spontaneous fibrinolysis.^b No clear-cut evidence for in vivo drug-induced thrombosis; however, the hazard of this theoretical complication remains a possibility.^b

CNS Effects

Neurological deficits (hydrocephalus, cerebral ischemia, cerebral vasospasm) associated with use of antifibrinolytic agents in the management of subarachnoid hemorrhage.^b Causal relationship to the drugs not established.^b

Specific Populations

Pregnancy

Category C.^b

Lactation

Not known if aminocaproic acid is distributed into milk; caution if used in nursing women.^b

Pediatric Use

Safety and efficacy not established.^b ¹¹¹

Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity (fatal “gasping syndrome”) in neonates (see Warnings); each mL of aminocaproic acid injection in multiple-dose vials contains 9 mg of benzyl alcohol.^b

Common Adverse Effects

Nausea,^b vomiting,^b cramping,^a abdominal pain,^b diarrhea,^b dizziness,^b malaise,^b fever,^a conjunctival suffusion,^a dyspnea,^b nasal congestion,^b headache,^b edema,^b pruritus,^b rash.^b

Interactions for Aminocaproic Acid

Specific Drugs

Drug	Interaction
Anti-inhibitor coagulant complex	Increased risk of thrombosis^b
Factor IX complex	Increased risk of thrombosis^b

Aminocaproic Acid Pharmacokinetics

Absorption

Bioavailability

Rapidly and completely absorbed from the GI tract; peak plasma concentrations are attained within about 1 hour following a 5-g dose.^b ¹¹¹

Special Populations

Plasma concentrations may be higher in patients with severe renal impairment.^b

Distribution

Extent

Distributed through extravascular as well as intravascular compartments; penetrates human red blood cells and other body cells.^b

Not known if aminocaproic acid is distributed into milk.^b

Plasma Protein Binding

Not bound.^a

Elimination

Metabolism

The major portion of aminocaproic acid is not metabolized.^b ¹¹¹

Elimination Route

Eliminated principally in urine as unchanged drug (65%) and the adipic acid metabolite (11%).^b ¹¹¹

Half-life

2 hours.^b

Special Populations

Removed by hemodialysis; may be removed by peritoneal dialysis.^b ¹¹¹ ¹²¹

Stability

Storage

Oral

Tablets

15–30°C; tight containers.^b

Syrup

15–30°C; tight containers.^b Do not freeze.^b

Parenteral

Injection

15–30°C.^b Do not freeze.^b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextrose 5% in water
Sodium chloride 0.9%

Y-Site Compatibility^HID

Compatible
Fenoldopam mesylate

ActionsActions

Aminocaproic acid inhibits the activation of plasminogen; also inhibits the action of fibrinolysin (plasmin).^b

Advice to Patients

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.^b

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^b

Importance of advising patients of other important precautionary information.^b (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Aminocaproic Acid
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	1.25 g/5 mL	Amicar Syrup (with parabens)	Xanodyne
			Aminocaproic Acid Syrup	VersaPharm
	Tablets	500 mg	Amicar (with povidone; scored)	Xanodyne
			Aminocaproic Acid Tablets	VersaPharm
		1 g	Amicar (with povidone; scored)	Xanodyne
Parenteral	For injection concentrate, for IV infusion	250 mg/mL (5 g)	Amicar Intravenous (with benzyl alcohol 0.9%)	Xanodyne
			Aminocaproic Acid Injection (with benzyl alcohol 0.9%)	American Regent, Hospira

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Amicar 500MG Tablets (XANODYNE PHARMACEUTICALS INC): 30/$103.39 or 90/$285.98

Aminocaproic Acid 500MG Tablets (VERSAPHARM): 100/$186.47 or 300/$539.22

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Crouch ER Jr, Frenkel M. Aminocaproic acid in the treatment of traumatic hyphema. Am J Ophthalmol. 1976; 81:355-60. [IDIS 70329] [PubMed 769560]

101. McGetrick JJ, Jampol LM, Goldberg MF et al. Aminocaproic acid decreases secondary hemorrhage after traumatic hyphema. Arch Ophthalmol. 1983; 101:1031-3. [IDIS 172818] [PubMed 6870623]

102. Palmer DJ, Goldberg MF, Frenkel M et al. A comparison of two dose regimens of epsilon aminocaproic acid in the prevention and management of secondary traumatic hyphemas. Ophthalmology. 1986; 93:102-8. [PubMed 3951807]

103. Kutner B, Fourman S, Brein K et al. Aminocaproic acid reduces the risk of secondary hemorrhage in patients with traumatic hyphema. Arch Ophthalmol. 1987; 105:206-8. [IDIS 225461] [PubMed 3813951]

104. Goldfarb MS, Bulas KE, Rosenberg S et al. Aminocaproic acid treatment of recurrent postoperative hyphemas. Ann Ophthalmol. 1984; 16:690,692-3,696-7. [PubMed 6476703]

105. Goldberg MF. Antifibrinolytic agents in the management of traumatic hyphema. Arch Ophthalmol. 1983; 101:1029-30. [PubMed 6347147]

106. Love DC. Treatment of traumatic hyphema. JAMA. 1985; 253:345-6. [IDIS 194852] [PubMed 3965787]

107. Schwartz BS, Williams EC, Conlan MG et al. Epsilon-aminocaproic acid in the treatment of patients with acute promyelocytic leukemia and acquired alpha-2-plasmin inhibitor deficiency. Ann Intern Med. 1986; 105:873-7. [IDIS 223520] [PubMed 3465267]

108. Gardner FH, Helmer RE III. Aminocaproic acid: use in control of hemorrhage in patients with amegakaryocytic thrombocytopenia. JAMA. 1980; 243:35-7. [IDIS 107007] [PubMed 6965311]

109. Kang Y, Lewis JH, Navalgund A et al. Epsilon-aminocaproic acid for the treatment of fibrinolysis during liver transplantation. Anesthesiology. 1987 66:766-73. (IDIS 230629)

110. Immunex Corporation. Amicar (aminocaproic acid) syrup, tablets, and injection prescribing information. Seattle, WA; 1998 Apr 13.

111. Abbott Laboratories. Aminocaproic acid injection prescribing information. Chicago, IL; 1992 May.

112. Saba HI, Morelli GA, Logrono LA. Brief report: treatment of bleeding in hereditary hemorrhagic telangiectasia with aminocaproic acid. N Engl J Med. 1994; 330:1789-90. [IDIS 331546] [PubMed 8190155]

113. Phillips MD. Stopping bleeding in hereditary telangiectasia. N Engl J Med. 1994; 330:1822-3. [IDIS 331549] [PubMed 8190162]

114. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. [IDIS 175725] [PubMed 6889041]

115. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10-1. [PubMed 7188569]

116. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]

117. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]

118. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]

119. Food and Drug Administration. Orphan designations pursuant to section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414) to June 28, 1996. Rockville, MD; 1996 Jul.

120. Food and Drug Administration. Amicar (aminocaproic acid) syrup [September 14, 1999: Immunex]. MedWatch drug labeling changes. Rockville, MD; September 1999. From FDA website ().

121. Food and Drug Administration. Amicar (aminocaproic acid) tablets, injection, syrup [April 16, 1997: Immunex]. MedWatch drug labeling changes. Rockville, MD; April 1997. From FDA website ().

122. Mangano DT, for the Multicenter Study of Perioperative Ischemia Research Group. Aspirin and mortality from coronary bypass surgery. N Engl J Med. 2002; 347:1309-17. [IDIS 488783] [PubMed 12397188]

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:98.

a. AHFS drug information 2006. McEvoy GK, ed. Aminocaproic Acid. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1544-46.

b. Xanodyne Pharmaceuticals. Amicar (aminocaproic acid) injection, syrup, and tablets prescribing information. Florence, KY; 2004 Sep.

c. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356 8. [IDIS 175725] [PubMed 6889041]

d. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10 11.

e. Centers for Disease Control. Neonatal deaths associated with use of benzyl alcohol. MMWR. 1982; 31:290 1. [IDIS 150868] [PubMed 6810084]

f. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384 8. [IDIS 160823] [PubMed 7133084]

g. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288 92. [PubMed 6440575]

h. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344 6. [IDIS 181207] [PubMed 6695984]

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Fibrinolytic Bleeding

Monday, September 26, 2016

albuterol

al-BUE-ter-ol

Commonly used brand name(s)

In the U.S.

Proventil

Proventil Repetabs

Ventolin

Volmax

VoSpire ER

In Canada

Apo-Salvent Inhaler

Available Dosage Forms:

Tablet

Syrup

Tablet, Extended Release

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For albuterol

Albuterol is used to treat bronchospasm or wheezing in patients with reversible obstructive airway disease, such as asthma.

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

albuterol is available only with your doctor's prescription.

Before Using albuterol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For albuterol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to albuterol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol in children 2 years of age and older.

Geriatric

No information is available on the relationship of age to the effects of albuterol in geriatric patients. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking albuterol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using albuterol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alprenolol

Arotinolol

Atenolol

Atomoxetine

Befunolol

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Brofaromine

Bucindolol

Bupranolol

Carteolol

Carvedilol

Celiprolol

Clorgyline

Dilevalol

Esmolol

Furazolidone

Iproniazid

Isocarboxazid

Labetalol

Landiolol

Lazabemide

Levobetaxolol

Levobunolol

Linezolid

Mepindolol

Metipranolol

Metoprolol

Moclobemide

Nadolol

Nebivolol

Nialamide

Nipradilol

Oxprenolol

Pargyline

Penbutolol

Phenelzine

Pindolol

Procarbazine

Propranolol

Rasagiline

Selegiline

Sotalol

Talinolol

Tertatolol

Timolol

Toloxatone

Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of albuterol

Use albuterol only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking albuterol or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

Swallow the extended-release tablet whole with water or liquids. Do not break, crush, or chew the tablet.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of albuterol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of albuterol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For treatment of bronchospasm:
- For oral dosage form (syrup, tablets):
  - Adults and children older than 12 years of age—2 or 4 milligrams (mg) taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given 4 times per day.
  - Children 6 to 12 years of age—2 mg taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given 4 times per day.
  - Children 2 to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight per dose, given 3 times per day, and each dose will not be more than 2 mg. Your doctor may increase your dose as needed up to a maximum dose of 12 mg per day, divided and given 3 times a day.
  - Children younger than 2 years of age—Use and dose must be determined by your child's doctor.
- For oral dosage form (extended-release tablets):
  - Adults and children older than 12 years of age—8 milligrams (mg) every 12 hours. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given every 12 hours.
  - Children 6 to 12 years of age—4 mg every 12 hours. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given every 12 hours.
  - Children younger than 6 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of albuterol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using albuterol

It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

albuterol may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using albuterol.

You or your child may also be taking an antiinflammatory medicine, such as a steroid, together with albuterol. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause allergic reactions. Stop using the medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, swelling, or any type of allergic reaction after taking albuterol.

Hypokalemia (low potassium in the blood) may occur while you are using albuterol. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

albuterol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

Less common

Fast, irregular, pounding, or racing heartbeat or pulse

Rare

Cough

difficulty breathing

difficulty with swallowing

hives or welts

hoarseness

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

noisy breathing

redness of the skin

shortness of breath

skin rash

slow or irregular breathing

swelling of the mouth or throat

tightness in the chest

wheezing

Incidence not known

Agitation

anxiety

arm, back, or jaw pain

blurred vision

chest pain or discomfort

confusion

convulsions

extra heartbeats

fainting

hallucinations

headache

irritability

lightheadedness

mood or mental changes

muscle pain or cramps

muscle spasm or jerking of all extremities

nervousness

nightmares

pounding in the ears

restlessness

sudden loss of consciousness

sweating

total body jerking

unusual feeling of excitement

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Dizziness

feeling of warmth

irritability

nausea

redness of the face, neck, arms, and occasionally, upper chest

sleeplessness

trouble with holding or releasing urine

trouble sleeping

unable to sleep

Rare

Sleepiness

unusual drowsiness

Incidence not known

Bad, unusual, or unpleasant (after) taste

change in taste

feeling of constant movement of self or surroundings

gagging

rough, scratchy sound to voice

sensation of spinning

tightness in the throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: albuterol side effects (in more detail)

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Albuterol Drug Interactions
Albuterol Support Group
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