Minocycline 135mg ER Capsules

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 effects. For 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, 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to urinate
+ 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 sunburning
+ 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
+ Vision problems (blurred vision, double vision, or loss of vision)
Thyroid cancer (reported with long-term use), which may cause:
+ Lasting hoarseness
+ Neck mass
+ Difficulty 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 Possible Side Effects

Most people do not experience side effects or only have mild side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention:

Diarrhea
Upset stomach or vomiting
Decreased appetite
* Dizziness, drowsiness, tiredness, or weakness

Reporting Side Effects

If you have questions about side effects or experience any side effects that bother you or do not go away, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at 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 signs and symptoms 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 (prescription, over-the-counter, natural products, and vitamins) and health issues 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. 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 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 you to sunburn more easily. If you experience increased sensitivity to the sun, inform your doctor.

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 rare, tooth discoloration has also been reported in adults, which typically resolves after discontinuing 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, use an additional form of birth control, such as a condom, in conjunction with your regular birth control method.

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)
• Oral Retinoids (e.g., Acitretin, Bexarotene) (increased risk of pseudotumor cerebri)
• Methoxyflurane (increased risk of nephrotoxicity)

• Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption)
• Iron preparations (decreased minocycline absorption)
• Bismuth subsalicylate (decreased minocycline absorption)
• Oral contraceptives (potential for decreased efficacy of oral contraceptives, though evidence is limited and controversial)
• Warfarin and other anticoagulants (may potentiate anticoagulant effect)
• Penicillins (tetracyclines may interfere with the bactericidal action of penicillin)

• Headache
• Blurred vision
• Dizziness
• Vertigo
• Nausea
• Vomiting
• Diarrhea
• Photosensitivity (sunburn-like reaction)
• Skin discoloration (blue-gray pigmentation)
• Tooth discoloration (in children)
• Joint pain/swelling
• Fever
• Rash
• Sore throat
• Unusual bleeding or bruising

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

Use with caution (L3). Minocycline is excreted into breast milk. While absorption by the infant 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. Monitor infant for diarrhea, candidiasis, and tooth discoloration.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration and enamel hypoplasia. Use in adolescents (12 years and older) for acne is generally accepted, but careful consideration of risks vs. benefits is necessary.

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

• Minocycline ER is specifically formulated for once-daily dosing and is primarily indicated for acne vulgaris.
• Counsel patients extensively on photosensitivity and the importance of sun protection.
• Warn patients about potential for dizziness/vertigo, especially at the start of therapy.
• Educate patients about the risk of permanent tooth discoloration if used in children under 8 years.
• Be aware of the rare but serious adverse effects like pseudotumor cerebri, DRESS syndrome, and drug-induced lupus-like syndrome.
• Advise patients to take with plenty of water and remain upright to prevent esophageal irritation/ulceration.
• Monitor for signs of C. difficile-associated diarrhea (CDAD) if severe, persistent diarrhea occurs.

• Other oral tetracyclines (e.g., Doxycycline, Tetracycline) for acne or infections
• Topical retinoids (e.g., Tretinoin, Adapalene, Tazarotene) for acne
• Topical antibiotics (e.g., Clindamycin, Erythromycin) for acne
• Benzoyl peroxide for acne
• Oral isotretinoin for severe nodular acne
• Other systemic antibiotics (e.g., Macrolides, Cephalosporins) for bacterial infections (not typically for acne)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.