Anema133 ml

Anema is an osmotic (saline) laxative combination indicated for:

• Established/approved use: Relief of occasional constipation (short-term use, oral solution).
• Established/approved use: Cleansing of the bowel as preparation for colonoscopy or other bowel examinations/procedures, usually as part of a bowel-preparation regimen that includes adequate oral fluid intake (oral solution, taken in divided doses as directed by a physician).
• Established/approved use: Rectal enema formulations of Anema are indicated for the relief of occasional constipation.

Anema is not intended for chronic or repeated use and should be used strictly according to the dose and frequency on the product label or as directed by a physician.

Diabasic Sodium Phosphate + Monobasic Sodium Phosphate combines two sodium phosphate salts that together provide the osmotic laxative effect:

• Monobasic sodium phosphate (monohydrate)
• Dibasic/diabasic sodium phosphate (heptahydrate)

The exact strength per mL or per dose unit varies by formulation (oral solution vs. rectal enema) and is specified on the individual product label.

Anema is a combination saline laxative made up of two sodium phosphate salts. It is formulated as an oral solution for bowel cleansing/relief of constipation, or as a ready-to-use rectal enema for relief of occasional constipation. It works by drawing water into the bowel to produce a bowel movement within a short period after administration.

Anema belongs to the therapeutic class of saline (osmotic) laxatives / bowel evacuants.

Diabasic Sodium Phosphate + Monobasic Sodium Phosphate acts as a hyperosmotic saline laxative. The phosphate salts are poorly absorbed from the gastrointestinal tract and osmotically draw water into the intestinal lumen. This increases intraluminal volume, distends the bowel, and stimulates peristalsis, resulting in evacuation of the bowel, typically within 30 minutes to a few hours of oral dosing, or more rapidly (within about 2-5 minutes) with rectal enema use.

A portion of the administered phosphate and sodium can be absorbed systemically, which is the basis for the electrolyte disturbances (see Precautions and Side Effects) that can occur, especially with excessive dosing or in patients with impaired renal function.

• Oral solution: Dilute with the recommended amount of water as directed on the label and drink promptly. Follow with additional clear fluids as instructed, especially when used for bowel cleansing before a procedure.
• Rectal enema: For rectal use only. Administer as a single dose using the pre-filled applicator, with the patient lying on their side, following the instructions provided with the product.

Do not take the rectal enema formulation of Anema by mouth, and do not use the oral solution rectally.

Clinically significant interactions with Anema include:

• Diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs), and NSAIDs: These agents can reduce renal blood flow or alter renal handling of sodium/phosphate, increasing the risk of acute kidney injury (including phosphate nephropathy) and electrolyte disturbance when combined with Anema; use together only with medical guidance and adequate hydration.
• Other oral medications: Because Anema accelerates bowel transit, it may reduce the absorption of orally administered drugs taken at the same time; separate dosing where possible.
• Other laxatives or bowel-preparation agents: Concurrent use with other osmotic or stimulant laxatives increases the risk of dehydration and electrolyte imbalance; avoid combining bowel-preparation products unless specifically directed by a physician.

Common, generally mild side effects of Anema include:

• Nausea, vomiting
• Abdominal bloating, cramping, or discomfort
• Anal/rectal irritation (with enema use)

Serious but less common effects: significant electrolyte disturbances (hyperphosphatemia, hypocalcemia, hypernatremia) and dehydration; rarely, acute phosphate nephropathy (a form of acute kidney injury) has been reported, particularly with excessive dosing or in at-risk patients (see Precautions and Warnings and Contraindications). Seek prompt medical attention for severe abdominal pain, reduced urination, unusual weakness, or signs of dehydration.

Data on the use of Anema in pregnancy are limited. It should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; consult a physician before use. There is limited information on excretion into breast milk; use during breastfeeding only under medical advice, weighing benefits against potential risks, and monitor the mother for electrolyte disturbances if used.

Use Anema with caution and only as directed on the label:

• Serious, sometimes fatal, electrolyte disturbances (hyperphosphatemia, hypocalcemia, hypernatremia) and dehydration have been reported with sodium phosphate bowel-cleansing products, particularly with excessive dosing, in elderly patients, or in those with even mild-to-moderate pre-existing renal impairment.
• Use the lowest effective dose in line with the label, ensure adequate hydration before and after use, and avoid use in patients at higher risk of complications (elderly, renal impairment, dehydration, heart failure).
• Do not exceed the labeled maximum dose or frequency; do not use multiple doses in a short period for bowel preparation without direct medical guidance.
• Avoid rectal enema use in young children in line with labeled age restrictions, given the same electrolyte/absorption concerns seen with oral use.
• Discontinue and seek medical attention if severe abdominal pain, rectal bleeding, or signs of dehydration or electrolyte imbalance occur.

Overdose or excessive/repeated use of Anema can cause severe electrolyte disturbances (hyperphosphatemia, hypocalcemia, hypernatremia), dehydration, and acute kidney injury, which can be serious or life-threatening, especially in the elderly or those with reduced kidney function. If overdose is suspected, seek immediate medical attention or contact emergency services/a poison control center. Do not attempt specific home treatment; management requires medical evaluation, monitoring of electrolytes and renal function, and supportive care as determined by a physician.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Renal impairment: Anema should generally be avoided in patients with significant renal impairment because of the risk of acute phosphate nephropathy (see Contraindications); use extreme caution and medical supervision in mild impairment.
• Elderly: Higher risk of electrolyte disturbance and dehydration; use the lowest effective dose with adequate hydration and monitoring.
• Pediatric patients: Use only under direct medical supervision; rectal enema use should generally be avoided in young children per labeled age restrictions (see Pediatric Uses).
• Pregnancy and lactation: See Pregnancy and Lactation section.
• Hepatic impairment: No well-established specific dose adjustment; use with general caution as for any patient at risk of fluid/electrolyte imbalance.

Anema is intended for short-term, occasional use only - either a single bowel-preparation course before a procedure or occasional relief of constipation. It is not intended for regular or prolonged use. If constipation persists beyond a few days despite use, or if bowel cleansing needs to be repeated frequently, consult a physician.

Saline laxatives; osmotic laxatives; bowel evacuants/bowel-preparation agents.

Diabasic Sodium Phosphate + Monobasic Sodium Phosphate works osmotically: the poorly absorbed phosphate salts draw water into the bowel lumen, increasing intraluminal fluid volume and distending the bowel wall, which stimulates peristalsis and produces evacuation of the bowel contents.

The safety and efficacy of Anema in children have not been well established for all formulations and age groups. When used for bowel preparation in children, it should be given only under direct medical supervision using a physician-directed, weight-based protocol. Rectal enema formulations of Anema should generally be avoided in young children (per labeled age restrictions) because of increased risk of electrolyte and fluid absorption relative to body size.