Revocit210 mg

Established / FDA-Approved Uses

• Control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) who are on dialysis (hemodialysis or peritoneal dialysis). Revocit is used as a phosphate binder to reduce hyperphosphatemia in this population.
• Treatment of iron deficiency anemia in adult patients with chronic kidney disease who are not on dialysis. Revocit is used as an oral iron replacement product in this setting.

Revocit has two distinct, FDA-approved indications depending on the clinical context (phosphate control on dialysis vs. anemia treatment off dialysis), and the dosing target differs accordingly (serum phosphorus vs. hemoglobin).

Each film-coated tablet of Ferric Citrate typically contains ferric citrate equivalent to approximately 210 mg of ferric iron (marketed in Bangladesh as 210 mg tablets). The tablet core also contains standard pharmaceutical excipients.

Revocit is an iron-based, orally administered medicine that functions both as a phosphate binder and as a source of absorbable iron. It is a coordination compound of ferric iron and citric acid, presented as a film-coated tablet for oral use.

Revocit is indicated for use in adults with chronic kidney disease, either to control elevated serum phosphorus levels in patients on dialysis, or to treat iron deficiency anemia in patients not yet requiring dialysis.

Phosphate binder (iron-based) and oral iron replacement product; classified within oral iron preparations used in the management of chronic kidney disease-related complications.

Mechanism in Hyperphosphatemia

In the gastrointestinal tract, the ferric iron component of Ferric Citrate binds dietary phosphate, forming insoluble ferric phosphate complexes. These complexes are not absorbed and are eliminated in the feces, thereby lowering serum phosphorus concentrations in patients with reduced renal phosphate clearance.

Mechanism in Iron Deficiency Anemia

A portion of the ferric iron in Ferric Citrate is reduced to the ferrous form and absorbed across the intestinal mucosa. Absorbed iron is bound to transferrin and delivered for incorporation into hemoglobin, increasing serum iron parameters (ferritin, transferrin saturation) and hemoglobin over time.

Revocit tablets should be taken orally with meals, swallowed whole with water. Do not crush or chew the tablets, as this can discolor the teeth and mouth. Consistent administration with each meal helps maximize the phosphate-binding effect and supports steady iron absorption.

Clinically Significant Interactions

• Doxycycline: Revocit can reduce the absorption of doxycycline through iron chelation; separate administration by at least 1 hour.
• Ciprofloxacin (and other fluoroquinolones): Iron in Revocit can chelate fluoroquinolones and reduce their absorption/efficacy; separate administration by at least 2 hours.
• Concurrent oral or intravenous iron supplementation: Concomitant use with other iron-containing products increases the risk of iron overload; iron status (ferritin, transferrin saturation) should be monitored closely and doses of supplemental iron adjusted or discontinued as needed.
• Drugs requiring an acidic gastric environment or specific absorption windows: Because Revocit can alter local pH and bind co-administered agents, drugs with narrow therapeutic indices or pH-dependent absorption should generally be separated from Revocit dosing; consult product-specific interaction guidance.

Many commonly used medications (e.g., statins, beta-blockers, warfarin) do not require dose separation from Revocit, but any new medication should be reviewed with a physician or pharmacist.

The most common side effects of Revocit are gastrointestinal and generally dose-related, often improving with continued use:

• Discolored (dark or black) stool - an expected effect of the iron content, not necessarily a sign of gastrointestinal bleeding; however, persistent or severe gastrointestinal symptoms should be evaluated by a physician.
• Diarrhea (most common, reported in roughly one-fifth of patients)
• Nausea
• Constipation
• Vomiting
• Abdominal pain, cough
• Hyperkalemia (elevated blood potassium) has also been reported

Iron overload (elevated ferritin/transferrin saturation) can occur with excessive intake - see Contraindications and Precautions.

Data on the use of Revocit during pregnancy are limited. Revocit 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.

It is not known whether the iron from Revocit is excreted into human breast milk in clinically significant amounts. Because iron is a normal component of breast milk, caution and physician guidance are advised, particularly regarding maternal iron status, before and during use of Revocit while breastfeeding.

Key Precautions

• Iron overload: Revocit increases iron absorption; monitor iron parameters (ferritin, transferrin saturation) periodically, especially in patients receiving concurrent oral or intravenous iron therapy, due to additive iron overload risk (see Contraindications for absolute iron-overload states).
• Must be taken with meals: The phosphate-binding effect of Revocit depends on co-administration with food; taking it apart from meals reduces effectiveness for phosphate control.
• Stool discoloration: Dark or black stools are an expected, benign effect of Revocit; however, unexplained or persistent gastrointestinal symptoms (e.g., severe abdominal pain, true melena with other signs of bleeding) warrant medical evaluation.
• Accidental pediatric ingestion: Iron-containing products, including Revocit, can be highly toxic if accidentally ingested by young children; store out of reach of children.
• Altered drug absorption: Medicines with narrow therapeutic windows or specific absorption requirements may need dose separation from Revocit (see Interactions).

Overdose of Revocit can lead to excessive iron absorption and iron toxicity, as well as pronounced gastrointestinal symptoms. Accidental ingestion by children is particularly dangerous and can be life-threatening.

If an overdose of Revocit is suspected, seek immediate medical attention or contact a poison control center/emergency services right away. Do not attempt specific home treatment; management of iron overdose requires prompt medical assessment and may involve supportive care and, in a hospital setting, specific treatment for iron toxicity under close medical supervision.

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

Renal Impairment

Revocit is specifically indicated for use in patients with chronic kidney disease (both on and not on dialysis); dosing is individualized and titrated to disease-specific targets rather than by creatinine clearance.

Hepatic Impairment

No well-established dose adjustment is defined for hepatic impairment; use with appropriate clinical monitoring.

Elderly

No specific dose adjustment is required based on age alone, though elderly patients should be monitored as clinically appropriate.

Pediatric Patients

Safety and efficacy of Revocit have not been established in pediatric patients (see Pediatric Uses).

For control of serum phosphorus in patients on dialysis, Revocit is typically used as ongoing, long-term therapy for as long as dialysis and phosphate control are needed, with dose adjusted periodically based on serum phosphorus levels.

For treatment of iron deficiency anemia in non-dialysis CKD, Revocit is generally continued until hemoglobin and iron parameters reach target levels, with ongoing use and dose reassessed by a physician based on response and iron status.

Phosphate binder (iron-based); oral iron replacement product / oral iron preparation.

Ferric Citrate acts through two related mechanisms: in the gut, its ferric iron binds dietary phosphate to form insoluble ferric phosphate that is excreted in stool, lowering serum phosphorus; separately, a portion of its iron is absorbed, reduced to the ferrous state, and used by the body for hemoglobin synthesis, raising iron stores and hemoglobin in iron deficiency anemia.

The safety and efficacy of Revocit have not been established in pediatric patients, and it is not recommended for use in children. Iron-containing products such as Revocit carry a serious risk of toxicity if accidentally ingested by young children, and all iron-containing medicines should be kept in child-resistant packaging, out of reach and sight of children.