Domadol (Tramadol Hydrochloride)

Composition

Capsule: Each capsule contains: Tramadol Hydrochloride BP 50mg

Injections:

Domadol 50:

Each ml contains: Tramadol Hydrochloride ph.Eur 50mg

Water for injection BP qs

Domadol 100:

 Each ml contains: Tramadol Hydrochloride ph.Eur 100mg

Water for injection BP qs

Excipients:

Capsule: Dibasic Calcium Phosphate Anhydrous, Talc & Hard gelatin capsule.

Injection: Citric acid Anhydrous, Sodium Citrate & Water for injection

Dosage form: Capsule Injection

Category of distribution: prescription preparation

Description of products

Capsule: Size “2” hard gelatin capsule red body and black cap. DOMADOL printed in white on body and cap containing white powder.

Injections: A clear, colourless liquid, free from particles.

Tramadol Hydrochloride Capsule BP 50mg/Injections 50mg & 100mg

Class: Centrally acting analgesic

Manufacturer: Unichem Laboratories Ltd

Dosage Form: Capsule, Injection

Similar Brands:

Uses:

Domadol is indicated for the management of severe acute or chronic pain during or following diagnostic or surgical procedures.

Dosage:

For the treatment of painful conditions Domadol injection 50mg to 100mg can be given intramuscularly or intravenously as needed every 4-6 hours not exceeding 400mg per day. Domadol capsule can be administered orally in a dosage of 50/100mg every 4-6 hours as needed. The daily dose should not exceed more than 400mg per day. In patients above 75 years daily dose should not exceed 300mg. in patients with renal impairment the recommended dosage is 50mg to 100mg every 12 hours. In patients with liver cirrhosis the recommended dosage is 50mg every 12 hours.

For long term treatment the dosage of domadol requires to be individualized as risk of dependence cannot be entirely excluded. Domadol should not be given for longer than therapeutically necessary.

Domadol injection should be injected slowly when given by intravenous route.

Domadol should not be used after date of expiry.

Side Effects:

Domadol is well tolerated. Adverse effects possibly related to domadol are mild, transient and rare. These are anorexia, flatulence, vasodilation, orthostatic hypotension, syncope, tachycardia, palpitations, urinary retention, visual disturbances, anxiety, confusion, euphoria, nervousness, co-ordination disturbances, allergic reactions, skin rashes, urticaria and weight loss.

Warnings & Precautions:

Note: Respiratory depression is not reported with domadol. However, Domadol should be used with caution when administered with anaesthetic agents or alcohol to avoid risk of respiratory depression.

Domadol should be used with caution in patients with increased intracranial pressure, head injury, acute abdominal conditions and in patients who are dependent on opiods.

In rare cases convulsions have been observed in patients receiving Tramadol. Hence, Domadol should be used with caution in patients with epilepsy with risk for seizures and in patients taking MAO inhibitors, neuroleptics and other drugs that lower the seizure threshold.

Pregnancy & Lactation:

Domadol should be used during pregnancy and during labour only if the potential benefit justifies the potential risk to the foetus, because there are no adequate and well controlled studies for establishing safe use in pregnancy.

Drug Interactions:

Drugs that include hepatic enzymes like carbamazepines lower the plasma concentration and half life of tramadol and its metabolite. Domadol may enhance the sedative effects of CNS depressants. It may increase the risk of seizure in patients taking MAO inhibitors and neuroleptics.

Contraindications:

Domadol is contraindicated in patients with history of hypersensitivity of tramadol, or in cases of acute intoxication with alcohol, sedatives, hypnotics, tranquilizers, other centrally acting analgesics, opiods or psychotropic drugs.

Domadol should be used with caution and in reduced dosages in patients receiving CNS depressants like anesthetic agents, phenothiazines, tranquilizers, sedative hypnotics, opiods etc.

Domadol should be used with caution in patients with epilepsy, patients at the risk of seizures and along with the drugs like MAO inhibitors neuroleptics etc, that lower seizure threshold.

The safety and efficacy of domadol in newborn infants and patients below 16 years have not been established. Hence caution should be exercised for obstetrical preoperative use or for post delivery analgesia or for use in children.

Price: Ksh 130

Notes:

Price above is for capsules pack of 10s

Pack size: Capsule (10s), Injections (blister of 5 ampoules)

For capsule

Manufactured in india by

Unichem Laboratories Ltd, Unit-II, Village Bhatuli Kalan, Baddi, Dist, Solan (H.P) – 173 205.

For injections

Manufactured in India by:

Unichem Laboratories Ltd, Industrial Area, Meerut Road, Ghaziabad 201 003

Date of publication insert: September 2015 (13007876)