Diclegis

Diclegis

Manufacturer:

Exeltis

Distributor:

DKLL

Marketer:

Exeltis
Concise Prescribing Info
Contents
Doxylamine succinate 10 mg, pyridoxine HCl 10 mg
Indications/Uses
Nausea & vomiting in pregnant women who do not respond to conservative management.
Dosage/Direction for Use
Initially 2 tab at bedtime on Day 1. Continue 2 tab at bedtime if symptoms are adequately controlled. Persistent symptoms until afternoon of Day 2: Continue 2 tab at bedtime & 3 tab (1 tab in the morning & 2 tab at bedtime) on Day 3. Inadequately controlled symptoms on Day 3: Max of 4 tab (1 tab in the morning, & mid afternoon & 2 tab at bedtime).
Administration
Should be taken on an empty stomach: Diclegis should be taken on an empty stomach w/ a glass of water. Swallow whole, do not crush, split or chew.
Contraindications
Hypersensitivity to doxylamine succinate & other ethanolamine derivative.
Special Precautions
Patients w/ asthma, increased IOP, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction & bladder-neck obstruction. May cause somnolence. Hyperemesis gravidarum. Gradually taper dose at discontinuation. Assess additional levels of vit B6 from diet & supplements. False +ve urine screening tests for methadone, opiates, & phencyclidine phosphate (PCP). Contains allura red AC Al lake (E129) which may cause allergic reactions. Not recommended to use concomitantly w/ CNS depressants including alcohol. May affect ability to drive & use machines. Lactation. Childn <18 yr.
Adverse Reactions
Somnolence. Dizziness; dry mouth; fatigue.
Drug Interactions
Prolonged & intensified anticholinergic effects of antihistamines w/ MAOIs. Severe drowsiness w/ CNS depressants including alcohol. Further delayed onset of action & reduced absorption w/ food. False +ve urine drug screens for methadone, opiates, & PCP.
MIMS Class
Antiemetics
ATC Classification
R06AA59 - doxylamine, combinations ; Belongs to the class of aminoalkyl ethers used as systemic antihistamines.
Presentation/Packing
Form
Diclegis gastro-resistant tab 10 mg/10 mg
Packing/Price
2 × 10's
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