Diclegis

Doxylamine succinate 10 mg, pyridoxine HCl 10 mg

Symptomatic treatment of nausea & vomiting of pregnancy in women who do not respond to conservative management.

Initially 2 tab at bedtime on day 1. If symptoms are adequately controlled the next day, continue taking 2 tab at bedtime. If symptoms persist in the afternoon of day 2, continue taking 2 tab at bedtime on day 2 & take 3 tab on day 3 (1 tab in the morning & 2 tab at bedtime). If symptoms are not adequately controlled on day 3, take 4 tab starting on day 4 (1 tab in the morning, 1 tab in the mid-afternoon & 2 tab at bedtime). Max recommended daily dose: 4 tab.

Should be taken on an empty stomach: Take on an empty stomach w/ a glass of water. Swallow whole, do not crush/split/chew.

Hypersensitivity. Porphyria. Concomitant use w/ MAOIs; potent CYP450 isoenzyme inhibitors.

Limited evidence in cases of hyperemesis gravidarum. May cause somnolence. May aggravate symptoms of dehydration & heat stroke. Hypokalemia or other electrolyte disturbances. Patients w/ increased IOP, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction & bladder-neck obstruction; asthma or other breathing disorders eg, chronic bronchitis & pulmonary emphysema; long QT syndrome. Epileptic patients. Avoid sunbathing during treatment. Carefully monitor for occurrence of signs suggestive of abuse or dependence especially in patients w/ history of drug use disorders. Discontinue use several days before allergy skin testing. Not recommended in concurrent use w/ CNS depressants including alcohol. Contains allura red AC aluminum lake (E129) which may cause allergic reactions. Avoid engaging in activities requiring complete mental alertness eg, driving or operating heavy machinery. Hepatic or renal impairment. Not recommended during lactation. Not recommended in childn <18 yr.

Somnolence. Dizziness; increased bronchial secretion; dry mouth; fatigue.

Delay in onset of action may be further delayed & reduction in absorption may occur w/ food. False +ve urine screening tests for methadone, opiates & PCP. Doxylamine: Toxicity may be enhanced w/ anticholinergic agents (TCAs, MAOI, neuroleptics). Hypnotic action may be enhanced w/ sedatives (barbiturates, benzodiazepines, antipsychotic agents, opioid analgesics). Sedative effect may be enhanced w/ antihypertensive drugs w/ sedative effect on CNS (especially α-methyldopa). Enhanced toxicity w/ alcohol. Not recommended in combination w/ Na oxybate. May mask warning signs of damage caused by ototoxic drugs eg, aminoglycosides, carboplatin, cisplatin, chloroquine & erythromycin. May cause additive photosensitizing effects w/ photosensitizing medications eg, amiodarone, quinidine, imipramine, doxepin, amitriptyline, griseofulvin, chlorpheniramine, piroxicam, furosemide, captopril. Avoid concomitant use of drugs that prolong QT interval eg, antiarrhythmic drugs, certain antibiotics, drugs for malaria, antihistaminic drugs, antilipidemic drugs or neuroleptic agents; CYP450 inhibitors eg, azole derivatives, macrolides; drugs that cause electrolyte disturbances eg, hypokalemia or hypomagnesemia eg, some diuretics. False -ve in dermal hypersensitivity tests w/ antigen extr. Pyridoxine: Reduced effect of l-dopa. Reduced plasma levels of some antiepileptics eg, phenobarb & phenytoin. Hydroxyzine, INH or penicillamine may interfere w/ & increase requirements for pyridoxine.

Antiemetics / Antihistamines & Antiallergics

R06AA59 - doxylamine, combinations ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines.

Rx