Meclozine hydrochloride, pyridoxine hydrochloride.
Each tablet contains: Meclozine Hydrochloride 25 mg.
Pyridoxine Hydrochloride 50 mg.
Pharmacology: Meclozine is a piperazine derivative with the properties of antihistamines. It has Central Nervous System (CNS) depressant, anticholinergic, antiemetic, antispasmodic, and local anesthetic effects in addition to antihistaminic activity. The drug depresses labyrinth excitability and conduction in vestibular-cerebellar pathways. The antiemetic and antimotion-sickness actions of Meclozine result, at least in part, from its central anticholinergic and CNS depressant properties.
The onset of action of Meclozine is about 1 hour and the drug has prolonged duration of action, with effects persisting 8 to 24 hours following administration of a single oral dose. The drug has a plasma half-life of 6 hours. The metabolic rate of Meclozine in humans is unknown. In rats, Meclozine is metabolized (probably in the liver) to norchlorcyclizine. This metabolite is distributed throughout most body tissues and crosses the placenta. The drug is excreted in faeces unchanged and in urine as norchlorcyclizine.
Pyridoxine is a water-soluble, B complex vitamin. It has been used for the management of vertigo, motion sickness, depression associated with pregnancy.
Pyridoxine is readily absorbed from the gastrointestinal (GI) tract after oral doses and is converted to the active forms pyridoxal phosphate and pyridoxamine phosphate. They are stored mainly in the liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites which are excreted in the urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.
For the prevention and treatment of nausea, vomiting or vertigo associated with motion sickness and other vestibular disorders.
For oral administration only.
Motion Sickness: Adults: Take 1 to 2 tablets once daily, 1 hour before traveling or exposure to motion. This dose may be repeated every 24 hours if necessary.
Children 6 to 12 years: Give 1/2 to 1 tablet once daily, 1 hour before traveling or exposure to motion or as directed by physician.
Vertigo and Vestibular Disorders: Adults: Take 1 to 4 tablets daily in divided doses or as directed by physician. Take each dose with a full glass of water. Do not exceed the recommended dose unless otherwise prescribed by physician.
Sign and Symptoms of Overdose and Treatment: In adults, the usual signs of Meclozine overdose are CNS depression with drowsiness, coma and convulsions. Hypotension may also occur, particularly in the elderly. In children, anticholinergic effects and CNS stimulation (hallucinations, seizures, trouble sleeping) are more likely to occur.
Symptoms of a pyridoxine overdose may include poor coordination, staggering, numbness, decreased sensation to touch, temperature and vibration.
There is no specific antidote for treatment of overdosage. Symptomatic and supportive treatment should be employed.
Not suitable for patients who have known hypersensitivity to Meclozine or Pyridoxine.
If symptoms persist, please consult a physician.
This medicine may cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drinks.
It should be used with caution for patients with asthma, angle-closure glaucoma or prostatic hypertrophy.
Patient should be warned that Meclozine may impair their ability to perform hazardous activities requiring mental alertness or physical coordination.
Long-term use of large doses of Pyridoxine is associated with the development of severe peripheral neuropathies.
Use in Pregnancy: Meclozine is classified by FDA as category B. There are no adequate and well-controlled studies in pregnant women or animals studies which have shown an adverse effect. This means that it is not expected to harm an unborn baby.
Pyridoxine is classified by FDA as category A. Therefore, it is considered to be safe for use during pregnancy. Pyridoxine requirements increase during pregnancy.
Use in Lactation: Meclozine may be distributed into breast milk. However, problems in humans have not been documented. Due to its anticholinergic actions, Meclozine may inhibit lactation. Therefore, it is not recommended for lactating women unless the expected benefits outweigh any potential risk.
Pyridoxine is excreted into milk. While some have expressed concern over the inhibition of breast milk secretion by Pyridoxine, others have cautioned that Pyridoxine deficiency may cause seizures in neonate.
Drowsiness, dry mouth, headache and GI disturbances have been reported and rarely caused blurred vision.
Meclozine has an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIs). It may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. In addition, the additive CNS depression may occur when Meclozine is administered concomitantly with other CNS depressants including barbiturates, tranquilizers, and alcohol. If Meclozine is used concomitantly with other depressant drugs, caution should be used to avoid overdosage.
Pyridoxine reduces the effects of levodopa, but this does not occur if a dopa decarboxylase inhibitor is also given. Pyridoxine reduces the activity of altretamine. It has also been reported to decrease serum concentrations of phenobarbital and phenytoin. Some drugs may increase the requirements for Pyridoxine; such drugs include hydralazine, isoniazid, penicillamine, and oral contraceptives.
Store below 30°C. Protect from direct sunlight, heat and moisture.
Shelf-Life: 3 years from the date of manufacture.
R06AE55 - meclozine, combinations ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Tab (white coloured, round with flat surface on both sides and scored on one side) 1 x 10's, 10 x 10's.