Duact

Duact uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse experiences
• Overdosage
• Dosage and administration
• How supplied
• Duact reviews

INDICATIONS AND USAGE

SEMPREX-D Capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. SEMPREX-D Capsules should be administered when both the antihistaminic activity of Duact and the nasal decongestant activity of pseudoephedrine are desired. The efficacy of SEMPREX-D Capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials.

SEMPREX-D Capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold.

CONTRAINDICATIONS

SEMPREX-D Capsules are contraindicated in patients with a known sensitivity to Duact, other alkylamine antihistamines (e.g., triprolidine), pseudoephedrine, other sympathomimetic amines (e.g., phenylpropanolamine), or to any other components of the formulation. SEMPREX-D Capsules are contraindicated in patients with severe hypertension or severe coronary artery disease. SEMPREX-D Capsules are contraindicated in patients taking monoamine oxidase (MAO) inhibitors and for 14 days after stopping use of an MAO inhibitor.

WARNINGS

SEMPREX-D Capsules should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, prostatic hypertrophy, stenosing peptic ulcer, or pyloroduodenal obstruction. Overdose of sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly are more likely to have adverse reactions to sympathomimetic amines.

PRECAUTIONS

General

Duact is sedating in some patients. In controlled clinical trials, somnolence was more common with SEMPREX-D Capsules (by an average of 6%) than with placebo.

Patients should be advised to assess their individual responses to SEMPREX-D Capsules before engaging in any activity requiring mental alertness, such as driving a motor vehicle or operating machinery. Concurrent use of SEMPREX-D Capsules with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of CNS performance and should be avoided.

Use In Patients With Diminished Renal Function

Duact and pseudoephedrine are excreted primarily through the kidney. Both compounds therefore accumulate in patients with impaired renal function. Due to the differential effects of renal failure on the serum half-life and clearance of Duact and pseudoephedrine, use of SEMPREX-D Capsules, a fixed combination product, in patients with renal impairment (creatinine clearance ≤ 48 mL/min) is not recommended.

Information To Patients

Patients taking SEMPREX-D Capsules should receive the following information. SEMPREX-D Capsules are prescribed to reduce symptoms associated with seasonal allergic rhinitis. Patients should be instructed to take SEMPREX-D Capsules only as prescribed and not to exceed the prescribed dose. Patients should be advised against the concurrent use of SEMPREX-D with over-the-counter antihistamines and decongestants. Patients who are or may become pregnant should be told that this product should be used in pregnancy or during lactation only if the potential benefit justifies the potential risks to the fetus or nursing infant. Due to the risk of hypertensive crisis, patients should be instructed not to take SEMPREX-D Capsules if they are presently taking a monoamine oxidase inhibitor or for 14 days after stopping use of an MAO inhibitor. Patients should be advised to assess their individual responses to SEMPREX-D Capsules before engaging in any activity requiring mental alertness, such as driving a car or operating machinery. Patients should be advised that the concurrent use of SEMPREX-D Capsules with alcohol and other CNS depressants may lead to additional reductions in alertness and impairment of CNS performance and should be avoided.

Drug Interactions

MAO inhibitors and beta-adrenergic agonists increase the effects of sympathomimetic amines. Concomitant use of sympathomimetic amines with MAO inhibitors can result in a hypertensive crisis. Because MAO inhibitors are long-acting, SEMPREX-D Capsules should not be taken with an MAO inhibitor or for 14 days after stopping use of an MAO inhibitor.

Because of their pseudoephedrine content, SEMPREX-D Capsules may reduce the antihypertensive effects of drugs that interfere with sympathetic activity. Care should be taken in the administration of SEMPREX-D Capsules concomitantly with other sympathomimetic amines because the combined effects on the cardiovascular system may be harmful to the patient.

Concomitant administration of SEMPREX-D Capsules with alcohol and other CNS depressants may result in additional reductions in alertness and impairment of CNS performance and should be avoided.

No formal drug interaction studies between SEMPREX-D Capsules and other possibly co-administered drugs have been performed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with the combination of Duact and pseudoephedrine have not been performed. Oral doses of Duact alone at levels up to 40 mg/kg/day for 20 to 22 months in rats and up to 250 mg/kg/day (750 mg/m²/day or 32 times the recommended human daily dose) for 20 to 24 months in mice revealed no evidence of carcinogenic potential. No evidence of mutagenicity (with or without metabolic activation) was observed in the Ames Salmonella mutagenicity assay or in the L5178Y/tk+/- mouse lymphoma assay. In an in vitro cytogenetic study performed in cultured human lymphocytes, Duact induced structural chromosomal abnormalities in the absence of metabolic activation, but not in its presence. In an in vivo cytogenetic study in rats given single oral doses of Duact up to 1000 mg/kg (5900 mg/m² or 249 times the recommended human daily dose) there were no structural chromosomal alterations.

Reproduction-fertility studies in rats given Duact alone at levels up to 200 mg/kg/day (1180 mg/m²/day or 50 times the recommended human daily dose) had no effect on male or female fertility. Similarly, no effect on fertility was seen in male rats given Duact 20 mg/kg/day and pseudoephedrine 100 mg/kg/ day (118 and 590 mg/m²/day or 5 and 3 times the recommended human daily doses, respectively) or in female rats given Duact 4 mg/kg/day and pseudoephedrine 20 mg/kg/day (23.6 and 118 mg/m²/day or 1 and 0.7 times the recommended human daily doses, respectively).

Pregnancy

Pregnancy Category B

Teratogenic Effects

No evidence of teratogenicity was seen in rats and rabbits given Duact 1000 and 400 mg/kg/day, respectively. No evidence of teratogenicity was seen in rats given a combination of Duact 30 mg/kg/day and pseudoephedrine 150 mg/kg/day (177 and 885 mg/m²/day or 8 and 5 times the recommended human daily dose, respectively). Similarly, no evidence of teratogenicity was observed in rabbits given Duact 20 mg/kg/day and pseudoephedrine 100 mg/kg/day (236 and 1180 mg/m²/day or 10 and 7 times the recommended human daily doses, respectively). There are, however, no adequate and well-controlled studies in pregnant women. Because animal teratology studies are not always predictive of human responses, SEMPREX-D Capsules should be used during pregnancy only if the potential benefit justifies the potential risks to the fetus.

Nonteratogenic Effects

In a perinatal-postnatal study in rats, Duact given alone at levels up to 500 mg/kg/day (2950 mg/m²/day or 124 times the recommended human daily dose) was associated with maternal and neonatal mortality at the maximum dose level. Neonatal survival was decreased in rats given a combination of Duact 20 mg/kg/day and pseudoephedrine 100 mg/ kg/day (118 and 590 mg/m²/day or 5 and 3 times the human dose, respectively).

Nursing Mothers

It is not known whether Duact is excreted in human milk; pseudoephedrine is excreted in human milk. SEMPREX-D Capsules should only be used in nursing mothers when the potential benefit justifies the potential risks to the nursing infant.

Pediatric Use

Safety and effectiveness of SEMPREX-D Capsules in pediatric patients under the age of 12 years have not been established.

Geriatric Use

Of the total number of subjects in clinical studies of SEMPREX-D, 349 were 60 years of age or older and 53 were 70 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Antihistamines, however, as a pharmaceutical class, are more likely to cause dizziness, sedation, bladder-neck obstruction, and hypotension in elderly patients. The elderly are also more likely to have adverse reactions to sympathomimetics such as pseudoephedrine.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Use of SEMPREX-D in patients with renal impairment (creatinine clearance ≤ 48 mL/min) is not recommended.

ADVERSE EXPERIENCES

Information on the incidence of adverse events in clinical investigations conducted in the U.S. was obtained from 33 controlled and 15 uncontrolled clinical studies in which 2499 patients received Duact and 2631 patients received Duact plus pseudoephedrine hydrochloride for treatment periods ranging from one day to one year. The majority of patients in clinical trials were exposed to Duact or Duact plus pseudoephedrine for less than 90 days. Duact dosage ranged from 3 to 96 mg/day; 1336 patients received dosages equal to or greater than Duact 24 mg/day. Duact plus pseudoephedrine hydrochloride dosages ranged from Duact 8 to 48 mg/day plus pseudoephedrine hydrochloride 60 to 240 mg/day. A total of 2335 patients received three or four daily doses of Duact 8 mg plus pseudoephedrine hydrochloride 60 mg.

In controlled clinical trials, only 12 spontaneously elicited adverse events were reported with frequencies greater than 1% in the Duact plus pseudoephedrine hydrochloride treatment group.

The nature and overall frequencies of adverse events from international clinical trials (35 studies involving approximately 1600 patients) were similar to the results obtained in the U.S. studies.

Post-marketing clinical experience reports with Duact and Duact plus pseudoephedrine have included rare serious hypersensitivity reactions manifested by anaphylaxis, angioedema, bronchospasm, and erythema multiforme. No deaths associated with use of Duact or Duact plus pseudoephedrine have been reported.

Pseudoephedrine may cause ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea.

OVERDOSAGE

There have been no reports of overdosage with Semprex-D Capsules. In the clinical trial program and in international post-marketing experience, there have been two reported overdoses with Duact. Doses were 72 mg and 322 mg. Both patients recovered without sequelae. Adverse events included trembling, stridor, loss of consciousness and possible convulsions in the first patient and somnolence in the second.

Since Duact and pseudoephedrine have pharmacologically different actions, it is difficult to predict how an individual will respond to overdosage with SEMPREX-D Capsules. However, acute overdosage with SEMPREX-D Capsules may produce clinical signs of either CNS stimulation or depression. Overdosage of sympathomimetics has been associated with the following events: fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Treatment for overdosage with SEMPREX-D Capsules should follow general symptomatic and supportive principles.

In a placebo-controlled, double-blind clinical trial in 18 healthy male subjects, single doses of Duact up to 400 mg (50 times the recommended antihistaminic dose) produced only a weak vagolytic effect, manifested as an increase in heart rate, and did not cause cardiac repolarization delays (i.e., increased QTc). Daily doses of Duact up to 2400 mg (75 times the recommended antihistamine dose) in an uncontrolled study in 38 cancer patients produced a 15-beats-per-minute increase in mean heart rate and occasional episodes of nausea and vomiting. The effects of Duact plus pseudoephedrine at single or multiple doses higher than the recommended daily dose of SEMPREX-D Capsules (i.e., 32 mg Duact plus 240 mg pseudoephedrine) on heart rate and cardiac repolarization have not been investigated in clinical trials.

The mean LD₅₀ (single, oral dose) of Duact is greater than 4000 mg/kg (23600 mg/m² or 1000 times the recommended human daily dose) in rats and greater than 1200 mg/kg (3600 mg/m² or 153 times the recommended human daily dose) in mice. The mean LD₅₀ (single, oral dose) of pseudoephedrine hydrochloride is 2206 mg/kg (13015 mg/m² or 73 times the recommended human daily dose) in rats and 726 mg/kg (2178 mg/m² or 12 times the recommended human daily dose) in mice. The toxic and lethal concentrations of Duact and pseudoephedrine in human biologic fluids are not known. Based upon pharmacokinetic screening data from clinical trials, the maximum plasma Duact concentration after dosing with Duact 8 mg was 393 ng/mL and the maximum plasma pseudoephedrine concentration after dosing with pseudoephedrine hydrochloride 60 mg was 1308 ng/mL.

DOSAGE AND ADMINISTRATION

The recommended dosage for adults and adolescents 12 years and older is one capsule administered orally, every 4 to 6 hours four times a day.

HOW SUPPLIED

SEMPREX-D Capsules contain Duact 8 mg and pseudoephedrine hydrochloride 60 mg. The cap is printed with “404” in white ink, and the body is printed with “SEMPREX-D” in black ink.

NDC 52244-404-10 Bottle of 100

Storage

Store at 15° to 25° C (59° to 77° F) in a dry place and protected from light.

Keep out of the reach of children.

For Medical Information, contact Actient Pharmaceuticals LLC at (877) 663-0412

Distributed by:

Actient Pharmaceuticals LLC

Chesterbrook, PA 19087

SEMPREX is a registered trademark of Actient Pharmaceuticals LLC, Chesterbrook, PA 19087

©Actient Pharmaceuticals LLC, Chesterbrook, PA 19087

All rights reserved.

03/2014

Pl-0314-006.a

013019

Duact pharmaceutical active ingredients containing related brand and generic drugs:

• Acrivastine
• Pseudoephedrine Hydrochloride

Duact available forms, composition, doses:

• Capsules; Oral; Acrivastine 8 mg; Pseudoephedrine Hydrochloride 60 mg

Duact destination | category:

• Human

Duact Anatomical Therapeutic Chemical codes:

• R06AX18 - Acrivastine

Duact pharmaceutical companies:

• GlaxoSmithKline

References

1. Dailymed."SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. Dailymed."PSEUDOEPHEDRINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Depending on the reaction of the Duact after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Duact not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology