Monograph Details
|
|
Pain & Pyrexia
> Migraine and headache
|
|
FIORINAL |
| Manufacturer |
|
Watson Pharmaceuticals, Inc. |
| Legal Classification |
|
CIII |
| Pharmacological Class |
|
Barbiturate + salicylate. |
| Generic Name |
|
Butalbital 50mg, aspirin 325mg, caffeine 40mg; tabs; caps. |
| Also |
|
• FIORINAL w. CODEINE
|
| Indications |
|
Tension (or muscle contraction) headache. |
| Children |
|
Not recommended. |
| Adults |
|
1–2 tabs or caps every 4 hours, as needed; max 6/day. |
| Contraindications |
|
NSAID allergy. Varicella or influenza in teenagers. Porphyria. Bleeding or coagulation disorders. Peptic ulcer. 3rd trimester pregnancy. |
| Precautions |
|
Drug abusers. Impaired hepatic or renal function. Acute abdomen. Depression. Suicidal tendencies. Asthma. Bleeding disorders. Gastritis. Monitor blood pressure, BUN, uric acid levels. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers: not recommended. For codeine: Head injury. Increased intracranial pressure. Impaired thyroid or adrenocortical function. GI stricture or urinary obstruction. Labor & delivery. |
| Interactions |
|
Potentiation with alcohol, CNS depressants, anticoagulants, hypoglycemics, insulin, plasma protein bound drugs, MAOIs, tricyclic antidepressants, anticholinergics. Alcohol, NSAIDs, corticosteroids increase risk of GI bleeding. May antagonize uricosurics, oral anticoagulants, antibiotics, corticosteroids. Induction of drug-metabolizing hepatic enzymes. Increased levels of 6-mercaptopurine, methotrexate. |
| Adverse Reactions |
|
Drowsiness, dizziness, sedation, shortness of breath, GI disturbances, abdominal pain, depression, prolonged bleeding time, paradoxical excitement, constipation, abuse potential, skin reactions, anaphylaxis; overdosage: respiratory depression, salicylism. |
| How Supplied |
Tabs—100, 1000
Caps—100, 500
With Codeine—100 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
