Consumer medicine information

1. Why am I using APO-Olmesartan?

APO-Olmesartan contains the active ingredient olmesartan medoxomil. APO-Olmesartan is used to treat high blood pressure, which is sometimes called hypertension.
For more information, see Section 1. Why am I using APO-Olmesartan? in the full CMI.

2. What should I know before I use APO-Olmesartan?

Do not use if you have ever had an allergic reaction to APO-Olmesartan or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use APO-Olmesartan? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-Olmesartan and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use APO-Olmesartan?

• The usual starting dose is 20mg once daily

• For children 6-18 years of age, (weighing more than 35 kg or more), the usual dose is 20mg once daily

• Do not give to children under one (1) year of age

5. What should I know while using APO-Olmesartan?

6. Are there any side effects?

Call your doctor immediately or go to the nearest emergency department if you feel any chest pains or develop any anaphylactic reactions; swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Olmesartan medoxomil.

2 Qualitative and Quantitative Composition

APO-Olmesartan contains the active ingredient olmesartan medoxomil.
APO-Olmesartan is available for oral use as film-coated tablets containing 20 mg, or 40 mg olmesartan medoxomil.
Excipients with known effect. Lactose monohydrate.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

20 mg tablet. Yellow film coated, round, biconvex tablets debossed with 323 on one side and L on the other side.
40 mg tablet. Yellow film coated, oval shape, biconvex tablets debossed with L324 on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

Only limited information is available regarding overdosage in humans. The most likely effect of overdosage is hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. In the event of overdosage, the patient should be carefully monitored and treatment should be symptomatic and supportive.
No information is available regarding the dialysability of olmesartan.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Both olmesartan medoxomil and olmesartan tested negative in the in vitro Syrian hamster embryo cell transformation assay and showed no evidence of genetic toxicity in the Ames (bacterial mutagenicity) test. However, both were shown to induce chromosomal aberrations in cultured cells in vitro (Chinese hamster lung) and tested positive for thymidine kinase mutations in the in vitro mouse lymphoma assay. Olmesartan medoxomil tested negative in vivo for mutations in the intestine and kidney of a mutagenic susceptible mouse (MutaMouse) and for clastogenicity in mouse bone marrow (micronucleus test) at oral doses of up to 2,000 mg/kg. Olmesartan not tested in this mouse model. On balance, the weight-of-evidence indicates that olmesartan medoxomil does not pose a genotoxic risk at clinically relevant doses.
Carcinogenicity. Olmesartan medoxomil was not carcinogenic when administered by dietary administration to rats for up to 2 years. The highest dose tested (2,000 mg/kg/day) corresponded to a relative systemic exposure to olmesartan that was about 30 times that anticipated at the maximum recommended human dose (MRHD) of 40 mg/day (based on AUC). Two carcinogenicity studies conducted in mice, a 6-month gavage study in the p53 knockout mouse and a 6-month dietary administration study in the Hras2 transgenic mouse, at doses of up to 1,000 mg/kg/day (about 11 times anticipated clinical exposure to olmesartan at the MRHD, based on AUC in Hras2), revealed no evidence of a carcinogenic effect of olmesartan medoxomil.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol.
Olmesartan medoxomil, a prodrug, is hydrolysed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT₁ subtype angiotensin II receptor antagonist.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSOLMMED.gif Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl] imidazole-5-carboxylate, cyclic 2,3-carbonate.
Its empirical formula is C₂₉H₃₀N₆O₆.
CAS number. 144689-63-4.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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