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Read the COA ( Certificate of Analysis ) for this medication. (PDF)
      For more information, please see Full Prescribing Information.

Phenobarbital may be habit forming. Tolerance and psychological and physical dependence may occur with continuing use. (See ADVERSE REACTIONS: Drug Abuse and Dependence.) Phenobarbital should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. Elderly or debilitated patients may react to Phenobarbital with marked excitement, depression, and confusion. In some persons, phenobarbital repeatedly produces excitement rather than depression.

In patients with hepatic damage, phenobarbital should be administered with caution and initially reduced doses. Phenobarbital should not be administered to patients showing the premonitory signs of hepatic coma.

Laboratory Tests
Prolonged therapy with phenobarbital should be accompanied by periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic systems (See General - above and ADVERSE REACTIONS.)

Human-data: A retrospective study of 84 children with brain tumors matched to 73 normal controls and 78 cancer controls (malignant disease other than brain tumors) suggested an association between exposure to barbiturates prenatally and an increased incidence of brain tumors.

Teratogenic effects: Pregnancy Category D. (See WARNINGS Use in Pregnancy.)

Nonteratogenic effects: Reports of infants suffering from long- term phenobarbital exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days. (See ADVERSE REACTIONS: Drug Abuse and Dependence.)

Labor and Delivery
Hypnotic doses of phenobarbital do not appear to significantly impair uterine activity during labor. Full anesthetic doses of phenobarbital decrease the force and frequency of uterine contractions. Administration of sedative-hypnotic phenobarbital to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects of phenobarbital. If phenobarbital is used during labor and delivery, resuscitation equipment should be available.

Data are currently not available to evaluate the effect of phenobarbital on the later growth, development, and functional maturation of the child.

Nursing Mothers
Caution should be exercised when phenobarbital is administered to a nursing woman since small amounts of phenobarbital are excreted in the milk.

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Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).




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