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• Dosage of Olmetrol in details
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Dosage of Olmetrol in details

Olmetrol Dosage

Generic name: Olmetrol MEDOXOMIL 5mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Adult Hypertension

Dosage must be individualized. The usual recommended starting dose of Olmetrol is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmetrol may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 mL/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate Olmetrol under close medical supervision and give consideration to use of a lower starting dose.

Olmetrol may be administered with or without food.

If blood pressure is not controlled by Olmetrol alone, a diuretic may be added. Olmetrol may be administered with other antihypertensive agents.

Pediatric Hypertension (6 to 16 years of age)

Dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of Olmetrol is 10 mg once daily for patients who weigh 20 to <35 kg (44 to 77 lb), or 20 mg once daily for patients who weigh ≥35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmetrol may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh ≥35 kg.

Children <1 year of age must not receive Olmetrol for hypertension.

For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension as described below. Follow the suspension preparation instructions below to administer Olmetrol as a suspension.

Preparation of Suspension (for 200 mL of a 2 mg/mL suspension)

Add 50 mL of Purified Water to an amber polyethylene terephthalate (PET) bottle containing twenty Olmetrol 20 mg tablets and allow to stand for a minimum of 5 minutes. Shake the container for at least 1 minute and allow the suspension to stand for at least 1 minute. Repeat 1-minute shaking and 1-minute standing for four additional times. Add 100 mL of Ora-Sweet®* and 50 mL of Ora-Plus®* to the suspension and shake well for at least 1 minute. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension well before each use and return promptly to the refrigerator.

* Ora-Sweet® and Ora-Plus® are registered trademarks of Paddock Laboratories, Inc.

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• Olmetrol (FDA)
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What other drugs will affect Olmetrol?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Olmetrol, especially:

• colesevelam;

• lithium;

• NSAIDs (non-steroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with Olmetrol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Olmetrol interactions

No significant drug interactions were reported in studies in which Olmetrol was co-administered with digoxin or warfarin in healthy volunteers.

The bioavailability of Olmetrol was not significantly altered by the co-administration of antacids [Al(OH)].

Olmetrol medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolized by those enzymes are not expected.

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Olmetrol medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Olmetrol medoxomil and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including Olmetrol medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.

Dual Blockade Of The Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on Olmetrol and other agents that affect the RAS.

Do not co-administer aliskiren with Olmetrol in patients with diabetes. Avoid use of aliskiren with Olmetrol in patients with renal impairment (GFR < 60 ml/min).

Colesevelam Hydrochloride

Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of Olmetrol. Administration of Olmetrol at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering Olmetrol at least 4 hours before the colesevelam hydrochloride dose.

Lithium

Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Olmetrol. Monitor serum lithium levels during concomitant use.

References

1. FDA/SPL Indexing Data. "8W1IQP3U10: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
2. MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology