Minocycline ER 135mg Tablets

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the attachment of aminoacyl-tRNA to the mRNA-ribosome complex. This leads to bacteriostatic activity. In acne, it also exhibits anti-inflammatory properties by inhibiting neutrophil chemotaxis and lipase activity of Propionibacterium acnes.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting.
Kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Lupus-like symptoms: rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
Fever, chills, or sore throat.
Unexplained bruising or bleeding, or feeling extremely tired or weak.
Changes in hearing.
Joint pain or swelling.
Muscle pain or weakness.
Ringing in the ears.
Seizures.
Shortness of breath.
Chest pain.
Abnormal heartbeat.
Swelling.
Darkening of skin, nails, eyes, scars, teeth, or gums.
Mouth irritation or sores.
Burning, numbness, or tingling sensations.
Redness or white patches in the mouth or throat.
Rectal or genital irritation.
Vaginal itching or discharge.

Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) can occur, which may lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor.

Liver Problems

Liver problems, including life-threatening cases, have been reported with this medication. If you notice any of the following symptoms, contact your doctor right away: dark urine, tiredness, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.

Raised Brain Pressure

Raised pressure in the brain has been reported with this medication, which may lead to loss of eyesight. If you experience headaches or eyesight problems, such as blurred vision, double vision, or loss of eyesight, contact your doctor immediately.

Thyroid Cancer

Cases of thyroid cancer have been reported with long-term use of this medication. If you notice lasting hoarseness, a neck mass, or difficulty breathing or swallowing, contact your doctor right away.

Severe Skin Reactions

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can be life-threatening and may affect other organs. If you experience any of the following symptoms, seek medical help immediately: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:

Diarrhea, nausea, or vomiting.
Decreased appetite.
Dizziness, drowsiness, tiredness, or weakness.

Reporting Side Effects

If you have questions about side effects or want to report any side effects, contact your doctor or the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
If you are pregnant or think you may be pregnant. Note that this medication is contraindicated during pregnancy.
If you are planning to become pregnant or father a child.
* If you are breastfeeding or plan to breastfeed. You may need to avoid breastfeeding while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to notify all healthcare providers and lab personnel that you are taking this drug.

Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection. When taking this medication, be cautious when exposed to sunlight, as it may increase your susceptibility to sunburn. If you experience unusual sunburn, inform your doctor promptly.

In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the change will be irreversible. Discuss any concerns with your doctor. This medication is not approved for use in children under 12 years old, and it is not recommended for children under 8 years old.

Although less common, tooth discoloration has also been reported in adults, which typically resolves after stopping the medication and undergoing dental cleaning. Consult your doctor if you have any concerns.

When taking this medication, birth control pills and other hormone-based contraceptives may be less effective. To prevent pregnancy, consider using an additional form of birth control, such as condoms.

If you are pregnant or become pregnant while taking this medication, it is crucial to contact your doctor immediately, as it may harm the unborn baby.

• Isotretinoin (increased risk of pseudotumor cerebri)
• Acitretin (increased risk of pseudotumor cerebri)

• Oral anticoagulants (e.g., Warfarin - may potentiate anticoagulant effect)
• Penicillins (may interfere with bactericidal action of penicillin)
• Ergot alkaloids (theoretical increased risk of ergotism)
• Live bacterial vaccines (e.g., Typhoid vaccine - may reduce efficacy)

• Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption)
• Iron preparations (decreased minocycline absorption)
• Bismuth subsalicylate (decreased minocycline absorption)
• Oral contraceptives (may decrease efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
• Barbiturates, Carbamazepine, Phenytoin (may decrease minocycline half-life)
• Methoxyflurane (increased risk of nephrotoxicity)

• Not available

• Headache (especially severe or persistent)
• Blurred vision or other visual disturbances
• Dizziness or vertigo
• Nausea, vomiting, diarrhea
• Skin rash or discoloration (blue-gray)
• Photosensitivity (severe sunburn)
• Joint pain or swelling
• Fever
• Sore throat
• Unusual bleeding or bruising
• Yellowing of skin or eyes (jaundice)
• Dark urine

Contraindicated in pregnancy (Category D). Tetracyclines can cause permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus, as well as reversible inhibition of bone growth. Use only if the potential benefit justifies the potential risk to the fetus.

Minocycline is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., tooth discoloration, inhibition of bone growth), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. L3 (Moderately Safe).

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration and inhibition of bone growth. Use in adolescents (≥ 12 years and ≥ 45 kg) for acne is based on adult studies.

No specific dose adjustment is generally required based on age alone. However, elderly patients may have age-related decreases in renal or hepatic function, which may warrant caution and monitoring. Increased susceptibility to dizziness/vertigo may occur.

• Minocycline ER is specifically formulated for once-daily dosing and should not be interchanged with immediate-release minocycline products.
• Advise patients to take with a full glass of water and remain upright for at least 30 minutes to minimize the risk of esophageal irritation/ulceration.
• Counsel patients extensively on photosensitivity and the importance of sun protection.
• Be aware of the potential for dizziness/vertigo, especially at the initiation of therapy, and advise patients accordingly.
• Monitor for signs of pseudotumor cerebri (idiopathic intracranial hypertension), which can manifest as severe headache, blurred vision, or papilledema. Discontinue if suspected.
• Long-term use can lead to blue-gray skin, nail, or tooth discoloration, which may be permanent.
• Consider drug-induced lupus erythematosus in patients on prolonged minocycline therapy who develop arthralgia, rash, or fever.

• Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
• Topical antibiotics (e.g., clindamycin, erythromycin)
• Benzoyl peroxide
• Oral retinoids (e.g., isotretinoin for severe recalcitrant acne)
• Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.