GLYCELAX 700/MG SUPP INFANTS 12/SUPP

Indications

Approved Uses

Short-term/occasional relief of constipation (to produce a bowel movement).

Off-Label Uses

No common/standard off-label uses for this OTC infant glycerin suppository.

Dosage & Administration

Dosing by Condition

Constipation (infants): 1 suppository (700 mg) rectally as needed for occasional constipation; if no response or if repeated dosing is needed, seek medical advice rather than routinely repeating within the same episode.

Initial Dose

One 700mg suppository rectally as a single dose

Maintenance Dose

One 700mg suppository per episode of constipation, not for daily routine use

Maximum Dose

Rectal: Insert 1 infant suppository (700 mg) into the rectum once daily as needed; do not exceed 1 suppository in 24 hours unless directed by a clinician.

Children's Dosage

Infants: One 700mg suppository rectally as needed. For older children, higher-strength suppositories (1000mg or 2000mg) are used

Dose Adjustment Notes

No dose adjustment is typically required; use intermittently/short-term only and avoid prolonged or frequent use unless medically advised.

How to Take

Unwrap/remove from blister; if soft, chill briefly; moisten with water (or water-based lubricant); place infant on side with knees flexed; gently insert into rectum (commonly pointed end first) and hold buttocks together briefly to prevent expulsion; expect bowel movement in ~15-30 minutes.

Side Effects

Common Side Effects

Rectal irritation/burning, rectal discomfort, abdominal cramping, and tenesmus/urge to defecate.

Side Effect Frequency

Common: rectal irritation/burning, mild abdominal cramping; Uncommon/Rare: diarrhea, rectal bleeding; Very rare: hypersensitivity reactions.

Safety & Warnings

Contraindications

Contraindicated in intestinal obstruction/ileus, acute surgical abdomen (e.g., appendicitis) or undiagnosed abdominal pain, and hypersensitivity to glycerin; avoid/use only with medical advice in rectal bleeding or significant anorectal disease (e.g., fissures, severe hemorrhoids/proctitis).

Warnings & Precautions

For rectal use only; do not use for >1 week without medical advice; do not use if severe abdominal pain, nausea/vomiting, or suspected obstruction; stop and seek medical care if rectal bleeding occurs or if no bowel movement occurs after use; ensure adequate fluids/dietary measures and avoid repeated use in very young infants without clinician guidance.

Age Restriction

Infant formulation (700 mg) may be used in infants/children when constipation is present; in neonates (<1 month) or children <2 years, use only on a clinician’s advice and seek medical review if constipation is persistent or recurrent.

Drug Interactions

Drug Interactions

No clinically significant drug interactions expected.

Interaction Severity

No clinically significant drug interactions known.

Food Interaction

No known clinically relevant food interactions (not applicable for rectal, locally acting product).

Special Populations

Children

Infants: One 700mg suppository rectally as needed. For older children, higher-strength suppositories (1000mg or 2000mg) are used

Kidney Impairment

No adjustment needed.

Storage & Patient Advice

Storage Conditions

Store below 30°C (per verified API); protect from excessive heat to prevent melting/softening; do not freeze; if softened from heat, chilling briefly to firm before use is acceptable but not a labeled storage requirement.

Missed Dose

Not applicable-use as needed; do not use on a fixed schedule unless directed by a clinician.

Stopping the Medicine

Safe to stop at any time; intended for occasional/short-term use only (do not continue beyond ~1 week without medical advice).

Overdose

Overdose via rectal use is unlikely; excessive use may cause diarrhea, abdominal cramping, rectal irritation and (with significant/prolonged diarrhea) dehydration/electrolyte disturbance; if accidentally swallowed, seek medical advice/poison center guidance.

Patient Counseling

Rectal use only; insert gently (usually pointed end first) and keep the child lying briefly; expect effect typically within 15-60 minutes; use for occasional constipation only and avoid prolonged/frequent use (seek medical advice if needing >3-7 days or recurrent constipation); stop and seek care if rectal bleeding, severe pain, vomiting, or no bowel movement after use; support with adequate fluids and age-appropriate diet; store below 30°C.

Monitoring Requirements

No routine laboratory monitoring; monitor for bowel movement/relief and for rectal irritation; seek medical advice if constipation persists, recurs frequently, or if bleeding/severe pain occurs.

Pharmacology

Mechanism of Action

Hyperosmotic laxative: draws water into the rectum/colon lumen to soften stool and increases local distension, stimulating rectal peristalsis and evacuation.

Onset of Action

Typically 15-30 minutes (may be up to ~60 minutes in some individuals).

Duration of Effect

Intended to produce a single bowel movement; effect typically occurs within 15-30 minutes after insertion.

Half-Life

Not applicable/clinically not meaningful (local rectal action with minimal systemic absorption).

Bioavailability

Minimal systemic absorption (acts locally in the rectum).

Metabolism

Minimal systemic metabolism due to poor absorption; any absorbed glycerol is metabolized via normal carbohydrate/lipid pathways (e.g., hepatic conversion to glucose/glycogen and entry into glycolysis).

Excretion

Primarily eliminated locally with stool; any small absorbed fraction is metabolized and ultimately excreted as CO2 and water, with minor renal excretion of metabolites.

Protein Binding

Negligible/none (not clinically relevant).

Product Information

Available Dosage Forms

Suppository (rectal).

Composition per Dose

Each suppository: 700mg glycerin

Generic Availability

Yes

OTC Alternatives

Other glycerin infant suppositories (same active ingredient/strength where available); non-pharmacologic measures (adequate fluids, age-appropriate dietary fiber/fruit purees); if an oral osmotic laxative is needed, lactulose is commonly used in infants but is often prescription-only depending on local regulation-confirm OTC status locally; avoid routine use of stimulant laxatives (e.g., bisacodyl) in infants unless clinician-directed.

Gi Condition

Constipation

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