Minocycline 55mg ER Tablets

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by binding reversibly to the 30S ribosomal subunit, thereby blocking the binding of aminoacyl tRNA to the mRNA-ribosome complex. This prevents the addition of new amino acids to the growing peptide chain. It also exhibits anti-inflammatory properties, which contribute to its efficacy in acne.

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Fever, chills, or sore throat
Unexplained bruising or bleeding
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
Changes in nail, skin, eye, scar, tooth, or gum color (darkening)
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
Diarrhea (common with antibiotics, but rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem)
Liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Raised pressure in the brain, which may cause:
+ Headache
+ Eyesight problems (blurred vision, double vision, or loss of vision)
Thyroid cancer (rarely reported with long-term use), which may cause:
+ Lasting hoarseness
+ Neck mass
+ Trouble breathing or swallowing
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs and can be life-threatening
+ Signs include:
- 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
- Swollen glands

Other Side Effects

Most people experience no side effects or only mild side effects when taking this medication. 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
Upset stomach 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 visit 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 might be pregnant. Do not take this medication if you are pregnant.
If you are trying to conceive 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 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 laboratory personnel that you are taking this drug.

Do not exceed the recommended duration of treatment, as this may increase the risk of a secondary 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 a permanent change in tooth color, resulting in a yellow-gray-brown discoloration. 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, so it is essential to consult with your doctor.

Children under 8 years old should not be given this medication. Although less common, 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 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 this drug may harm the unborn baby.

• Isotretinoin (increased risk of pseudotumor cerebri)

• Antacids (containing aluminum, calcium, magnesium) - decreased minocycline absorption
• Iron preparations - decreased minocycline absorption
• Bismuth subsalicylate - decreased minocycline absorption
• Dairy products / Food rich in calcium - decreased minocycline absorption
• Oral contraceptives - reduced efficacy of oral contraceptives (breakthrough bleeding, unintended pregnancy)
• Warfarin - enhanced anticoagulant effect (monitor INR)
• Penicillins - antagonistic effect (avoid concomitant use)
• Ergot alkaloids - increased risk of ergotism

• Methotrexate - increased methotrexate toxicity (rare, but monitor)
• Digoxin - increased digoxin absorption (monitor digoxin levels)
• Typhoid vaccine (live, oral) - reduced efficacy of vaccine

• Not available

• Headache (especially severe or persistent)
• Blurred vision or other visual disturbances
• Dizziness or vertigo
• Nausea, vomiting, diarrhea
• Skin rash, hives, or itching
• Increased sensitivity to sunlight (photosensitivity)
• Joint pain, muscle aches, or swelling
• Fever, chills, or flu-like symptoms
• Unusual fatigue or weakness
• Dark urine, yellowing of skin or eyes (jaundice)
• Unusual bleeding or bruising
• Sore throat, swollen glands
• Difficulty swallowing
• Chest pain or palpitations

Minocycline is classified as Pregnancy Category D. It is contraindicated during pregnancy due to the potential for permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the developing fetus. 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 effects in the nursing infant, including permanent tooth discoloration and inhibition of bone growth, minocycline is generally not recommended during breastfeeding. 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.

Minocycline is 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 older) for acne is common, but careful consideration of benefits vs. risks is warranted.

Use with caution in elderly patients, as they may be more susceptible to adverse effects, particularly renal or hepatic impairment. Monitor renal and hepatic function, and adjust dose if necessary. Increased risk of dizziness/vertigo may be more pronounced.

• Minocycline is unique among tetracyclines for its higher lipophilicity, leading to better tissue penetration, including the skin, which is beneficial for acne treatment.
• Unlike some other tetracyclines, minocycline is primarily eliminated via non-renal routes, making it a preferred tetracycline in patients with renal impairment, though caution is still advised.
• Patients should be advised about the potential for photosensitivity and encouraged to use sun protection.
• Minocycline can cause dizziness, lightheadedness, or vertigo, especially at the initiation of therapy or with higher doses. Patients should be cautioned about driving or operating machinery.
• Rare but serious side effects include drug-induced lupus-like syndrome, autoimmune hepatitis, and benign intracranial hypertension (pseudotumor cerebri). Patients should be educated on symptoms to watch for.
• Blue-gray skin discoloration (hyperpigmentation) can occur with long-term use, particularly in areas of inflammation or scarring, and may be permanent.

• Topical retinoids (e.g., tretinoin, adapalene, tazarotene) for acne
• Benzoyl peroxide for acne
• Topical antibiotics (e.g., clindamycin, erythromycin) for acne
• Other oral antibiotics (e.g., azithromycin, trimethoprim/sulfamethoxazole) for acne or other infections
• Hormonal therapies (e.g., oral contraceptives, spironolactone) for hormonal acne
• Isotretinoin (for severe, recalcitrant nodular acne)
• Other classes of antibiotics for bacterial infections (e.g., macrolides, fluoroquinolones, beta-lactams)

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 your 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.