Composition, Properties, Indications, Contraindications, Dosage and administration, Precautions, Side effects, Presentation, Storage, NAFDAC registration number and Manufacturer of Vitabiotics Phenobarbitone Tablet Medicine for Sedative.
Each tablet contains Phenobarbitone 30 mg.
Phenobarbitone is 5-ethyl-5-phenyl-1 H,3H,5H-pyrimidine-2, 4, 6-trione.
It has a hypnotic action, but in therapeutic doses. It has little or no effect on the medullary centers, so that blood pressure respiration are not influenced. It is excreted unchanged in the urine.
It is chiefly used as a sedative and hypnotic. It is also used as an antiepileptic to control partial and generalised tonic-clonic seizures. Phenobarbitone is also used as a sedative in nervous and anxiety states, chorea, neurasthenia, cIimacteric disorders, dysmenorrhoea, and thyrotoxicosis. It is indicated in all forms of epilepsy except absence of seizures.
It is contra-indicated in porphyrias. Also, it is detoxicated by the liver and is therefore contra-indicated where there is liver damage.
DOSAGE AND ADMINISTRATION
Adults: 3 tablets (90mg) at night.
Adults: 1 tablet (30 mg) to 2 tablets (60 mg) two or three times daily.
Children: (6 yrs -12 yrs): ½ tablet (15mg) three times daily.
Adults: 1 tablet (30 mg) to 2 tablets (60 mg) three times daily.
Children: (6 yrs -12 yrs): ½ tablet (15 mg) to 1 tablet (30 mg) three times daily.
Phenobarbitone may increase the rate of metabolism of other drugs such as folic acid, griseofulvin, phenylbutazone, phenytoin, and anticoagulants of the coumarin type, and caution should therefore be exercised in giving phenobarbitone with other drugs. It should be used with care in children and in elderly or debilitated patients, in those in acute pain, and in those with depressive disorders. Also, it should be given cautiously to patients with impaired hepatic, renal, or respiratory function and may be contra- indicated when the impairement is severe. Phenobarbitone causes drowsiness and patients receiving it, if affected should not take charge of vehicles or machinery where loss of attention could cause accidents.
As with other hypnotics, patients should avoid taking alcohol or other drugs acting on the central nervous system while under the influence of the treatment since withdrawal response cannot be foreseen. Sudden withdrawal of phenobarbitone from an epileptic should be avoided, as it may precipitate status epilepticus. Caution should be exercised also, in giving phenobarbitone in pregnancy, breast-feeding and severe respiratory depression.
The most frequent side-effects is sedation which becomes less marked with continued administration. It may produce subtle mood changes and memory that may not be apparent without testing. Depression may occur.
Prolonged administration may occasionally result in folate deficiency; rarely, megaloblastic anaemia has been reported. It interferes with vitamin D metabolism.
At high doses nystagmus and ataxia may occur and the typical barbiturate-induced respiratory depression may become severe. Overdosage can prove fatal, toxic effects include coma, severe respiratory and cardiovascular depression, with hypertension and shock leading to renal failure Hypothermia may occur, with associated pyrexia during recovery. Skin blisters (bullae) may also occur. Hypersensitivity reactions may occur; skin reactions which are most commonly maculopapular, morbilliform, or scariatiniform rashes may also occur. More severe reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis are extremely rare. Hepatitis and disturbances of liver function may as well occur.
In the elderly, paradoxical excitement, confusion and restlessness may occur while in children irritability and hyperactivity may sometimes occur. Neonatal drug dependence and symptoms resembling vitamin K deficiency occur in infants born to mothers who received phenobarbitone during pregnancy. Congenital malformations have been reported in children of women who received phenobarbitone.
Pack of 1000 tablets.
KEEP MEDICINES AWAY FROM CHILDREN.
KEEP IN A COOL, DARK AND DRY PLACE.
NAFDAC REG. NO.: 04-0074.
VITABIOTICS (NIG.) LTD.
35, Mobolaji Johnson Avenue.
Oregun Industrial Estate, Ikeja,