Tekral

Tekral Uses, Dosage, Side Effects, Food Interaction and all others data.

Trade Name Tekral
Generic Diphenhydramine hydrochloride + pseudoephedrine hydrochloride
Type Tablet, multilayer, extended release
Therapeutic Class
Manufacturer
Available Country United States
Last Updated: September 19, 2023 at 7:00 am
Tekral
Tekral

Uses

Diphenhydramine is indicated for the treatment of followings: Seasonal, perennial, vasomotor rhinitis Urticaria, angioneurotic oedema, anaphylaxis Pruiritic conditions Premedication for emesis and motion sickness Miscellaneous like meniere's disease and parkinsonismPseudoephedrine is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa, sinuses and eustachian tube. It is indicated for the symptomatic relief of allergic rhinitis (hay fever), vasomotor rhinitis, the common cold, influenza (flu) and ear congestion caused by ear inflammation or infection. Pseudoephedrine can also be used as a bronchodilator.

Dosage

Tekral dosage

Adult- Most allergic conditions: 25-50 mg three times a day with a further 50 mg at night. Children- 1 to 5 years of age: 5 mg i.e., 2.5 ml of elixir 4 times a day More than 6 years of age: 10 mg i.e. 5 ml of elixir 4 times a dayAs a decongestant and symptomatic treatment for upper respiratory tract infections the recommended dose is:Adults: 1 tablet every 4 to 6 hours, up to maximum of 240 mg in 24 hoursChildren: 6-12 years of age: 1/2 tablet every 4 to 6 hours daily 2-5 years of age: 1/4 tablet every 4 to 6 hours daily Less than 2 years of age: This drug is not advised unless specifically recommended by a physician.

Side Effects

Side effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.Serious adverse effects associated with the use of Pseudoephedrine are rare. Symptoms of central nervous system excitation may occur, including sleep disturbances and, rarely, hallucinations have been reported. Skin rashes, with or without irritation, have occasionally been reported.

Precaution

Caution should be exercised with patients in whom drowsiness is undesirable e.g., drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness.Although Pseudoephedrine has virtually no pressor effects in normotensive patients, it should be used with caution in patients suffering mild to moderate hypertension. As with other sympathomimetic agents, Pseudoephedrine should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment.

Interaction

Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicyclic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative action of Diphenhydramine. Anticholinergic drugs may potentiate Diphenhydramine’s anticholinergic side effects.

Pregnancy & Breastfeeding use

Category B: There are no adequate and well controlled studies in pregnant women using diphenhydramine hydrochloride. Therefore, diphenhydramine hydrochloride should be used in pregnancy only if clearly needed. Diphenhydramine hydrochloride has been reported to be excreted in breast milk and thus, use of diphenhydramine hydrochloride in lactating mother is not recommended.Although Pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus. Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known.

Contraindication

Known hypersensitivity to Diphenhydramine Hydrochloride, Ammonium chloride is contra-indicated in presence of impaired hepatic or renal function.Pseudoephedrine is contraindicated in- Hypersensitivity of individuals to this drug Severe hypertension and coronary artery disease Concurrent use of Mono Amine Oxidase Inhibitor (MAOI) drugs

Acute Overdose

Symptoms: Impaired consciousnessÍž psychosis, seizures, antimuscarinic symptoms (e.g. mydriasis, tachycardia, tachyarrhythmias), resp failure, rhabdomyolysis; acute delirium with visual and auditory hallucination (topical). Management: Supportive and symptomatic treatment. Convulsions and marked CNS stimulation may be treated with IV diazepam.As with other sympathomimetic agents, symptoms of overdosage include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition. Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. If desired, the elimination of Pseudoephedrine can be accelerated by acid diuresis or by dialysis.

Storage Condition

Store between 15-30° C. Protect from moisture.

Innovators Monograph

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