What Is Minolira?
Minolira (minocycline hydrochloride) extended-release tablets is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Minolira is available in generic form.
What Are Side Effects of Minolira?
Common side effects of Minolira include:
- headache,
- fatigue,
- dizziness,
- itching,
- feeling unwell (malaise),
- mood changes,
- drowsiness,
- hives,
- ringing in the ears (tinnitus),
- joint pain,
- spinning sensation (vertigo),
- dry mouth, and
- muscle pain.
Dosage for Minolira
The recommended dosage of Minolira is approximately 1 mg/kg once daily for 12 weeks.
What Drugs, Substances, or Supplements Interact with Minolira?
Minolira may interact with anticoagulants, penicillin, antacids, iron preparations, and low dose oral contraceptives. Tell your doctor all medications and supplements you use.
Minolira During Pregnancy and Breastfeeding
Minolira is not recommended for use during pregnancy; it may harm a fetus. The use of drugs of the tetracycline class such as Minolira during tooth development may inhibit bone growth and cause permanent discoloration of teeth. Minolira may reduce the effects of oral contraceptives. Talk to your doctor about birth control options while taking Minolira. Minolira passes into breast milk but its effects on a nursing infant are unknown. Breastfeeding is not recommended while using Minolira.
Additional Information
Our Minolira (minocycline hydrochloride) Extended-Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Skin Health: 15 Tips for Clear Skin See SlideshowGet emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, fever, swollen glands, joint pain, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Call your doctor at once if you have:
- bronchospasm (wheezing, chest tightness, trouble breathing);
- a seizure;
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
- low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
- increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, vision problems, pain behind your eyes; or
- signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, loss of appetite, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- numbness, tingling, burning pain;
- hair loss;
- discoloration of you skin or nails.
- dizziness, spinning sensation;
- muscle or joint pain;
- nausea, diarrhea, loss of appetite;
- swollen tongue, cough, trouble swallowing;
- rash, itching; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Acne is the result of an allergy. See AnswerSIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.
The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended release tablets.
Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial
| Adverse Reactions | Minocycline Hydrochloride Extended- Release Tablets (1 mg/kg) N = 674 (%) |
Placebo N = 364 (%) |
| At least one treatment emergency event | 379 (56) | 197 (54) |
| Headache | 152(23) | 83(23) |
| Fatigue | 62 (9) | 24 (7) |
| Dizziness | 59 (9) | 17 (5) |
| Pruritus | 31 (5) | 16 (4) |
| Malaise | 26 (4) | 9 (3) |
| Mood alteration | 17 (3) | 9 (3) |
| Somnolence | 13 (2) | 3 (1) |
| Urticaria | 10 (2) | 1 (0) |
| Tinnitus | 10 (2) | 5 (1) |
| Arthralgia | 9 (1) | 2 (0) |
| Vertigo | 8 (1) | 3 (1) |
| Dry Mouth | 7 (1) | 5 (1) |
| Myalgia | 7 (1) | 4 (1) |
Postmarketing Experience
Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include:
Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis, DRESS syndrome [see WARNINGS AND PRECAUTIONS].
Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupuslike syndrome.
Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.
Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function.
Oncology: thyroid cancer.
Oral: glossitis, dysphagia, tooth discoloration.
Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.
Genitourinary: Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis [see Nonclinical Toxicoloty].
Renal: reversible acute renal failure.
Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.
DRUG INTERACTIONS
Anticoagulants
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Penicillin
Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, to avoid giving tetracycline-class drugs in conjunction with penicillin.
Antacids And Iron Preparations
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.
Low Dose Oral Contraceptives
In a multi-center study to evaluate the effect of minocycline extended release tablets on low dose oral contraceptives, hormone levels over one menstrual cycle with and without minocycline extended release tablets 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, cannot be ruled out. To avoid contraceptive failure during treatment with minocycline, advise patients of reproductive potential to use a second form of contraception in addition to low-dose oral contraceptives.
Drug/Laboratory Test Interactions
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Read the entire FDA prescribing information for Minolira (Minocycline Hydrochloride Extended-Release Tablets)
© Minolira Patient Information is supplied by Cerner Multum, Inc. and Minolira Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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