Minocycline 105mg ER Tablets

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the binding of aminoacyl tRNA to the mRNA-ribosome complex. This leads to bacteriostatic activity against susceptible organisms. Its anti-inflammatory properties are also thought to contribute to its efficacy in acne.

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 symptoms: 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 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 the color of nails, skin, eyes, scars, teeth, or gums.
Mouth irritation or mouth 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, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can 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 first.

Liver Problems

Liver damage has been reported with this medication, and in some cases, it has been fatal. If you notice any signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor right away.

Raised Brain Pressure

This medication can cause increased pressure in the brain, which usually resolves after stopping the medication. However, in some cases, vision loss may occur and may be permanent. If you experience headaches or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor immediately.

Thyroid Cancer

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

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. 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, and many have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea, nausea, or vomiting.
Decreased appetite.
Dizziness, drowsiness, fatigue, 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 or have taken 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 not recommended 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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Do not 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 laboratory 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 cause increased sensitivity to sunburn. If you experience easy sunburning while on this medication, inform your doctor.

In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the discoloration will not fade. Discuss this risk with your doctor. This medication is not approved for use in children under 12 years old, so consult with your doctor to determine the best course of treatment.

Children under 8 years old should not be given this medication. Although rare, tooth discoloration has also been reported in adults, which typically reverses after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns about tooth discoloration.

When taking this medication, birth control pills and other hormone-based contraceptives may be less effective. To prevent pregnancy, use an additional form of birth control, such as a condom. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.

• Isotretinoin (increased risk of pseudotumor cerebri)
• Methoxyflurane (fatal renal toxicity)

• Anticoagulants (e.g., warfarin - potentiates anticoagulant effect)
• Penicillins (may interfere with bactericidal action of penicillin)
• Oral contraceptives (may reduce efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
• Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption)
• Iron preparations (decreased minocycline absorption)
• Bismuth subsalicylate (decreased minocycline absorption)

• Ergot alkaloids (theoretical increased risk of ergotism)
• Digoxin (may increase digoxin levels)
• Typhoid vaccine, live (tetracyclines may inactivate the vaccine)

• Sucralfate (decreased minocycline absorption)

• Headache (especially severe or persistent)
• Blurred vision or other visual disturbances (e.g., diplopia, loss of vision)
• Dizziness or lightheadedness
• Nausea, vomiting, diarrhea
• Photosensitivity (severe sunburn-like reaction)
• Skin rash or hives
• Yellowing of skin or eyes (jaundice)
• Darkening of skin, nails, or gums (hyperpigmentation)
• Joint pain or swelling (drug-induced lupus-like syndrome)

Contraindicated during pregnancy. Minocycline can cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus. It should only be used if the potential benefit justifies the potential risk to the fetus.

Use with caution. Minocycline is excreted into breast milk. While the amount is generally low, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth. Use in children 8 years and older for acne should be carefully considered and dosed appropriately.

No specific dose adjustment is generally required based on age alone. However, elderly patients are more likely to have age-related decreases in renal or hepatic function, which may necessitate dose adjustments or closer monitoring for adverse effects.

• Minocycline ER is specifically formulated for once-daily dosing and is often preferred for acne due to its anti-inflammatory properties in addition to its antibacterial action.
• Counsel patients extensively on photosensitivity and the importance of sun protection.
• Warn patients about potential dizziness, especially at the start of therapy, and advise caution with driving or operating machinery.
• Educate patients about the rare but serious risk of pseudotumor cerebri (benign intracranial hypertension) and to report any severe headaches or vision changes immediately.
• Advise patients that skin, nail, and gum discoloration can occur with long-term use, which may be permanent.
• Ensure patients understand the interaction with antacids, iron, and calcium, and the need to separate administration times.

• Other oral tetracyclines (e.g., doxycycline, sarecycline)
• Other oral antibiotics for acne (e.g., azithromycin, erythromycin, trimethoprim/sulfamethoxazole)
• Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
• Topical antibiotics (e.g., clindamycin, erythromycin)
• Benzoyl peroxide
• Oral retinoids (e.g., isotretinoin for severe acne)
• Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the overdose, including the medication taken, the amount, and the time it occurred.