Minocycline 65mg ER 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 the context of acne, minocycline also exhibits anti-inflammatory properties by inhibiting neutrophil chemotaxis, reducing pro-inflammatory cytokines, and inhibiting lipase activity of P. acnes, which reduces free fatty acid production.

Urgent Side Effects: Seek Medical Attention Immediately

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 or seek medical help right away:

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 to a darker shade
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) may occur, which can lead to a life-threatening bowel problem. 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 liver failure, have been reported with this medication. If you notice any of the following symptoms, contact your doctor right away:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
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 a headache 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 any of the following symptoms, contact your doctor right away:
Lasting hoarseness
Neck mass
Trouble breathing or swallowing

Severe Skin Reactions

Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with this medication. 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
Swollen glands

Other Side Effects

Most people do not experience significant side effects or only have minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical help:
Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness, drowsiness, tiredness, or weakness

Reporting Side Effects

If you have any questions or concerns about side effects, 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 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 issues 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 lab personnel that you are taking this drug.

Do not exceed the recommended 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, and it should not be given to children under 8 years old.

Although less common, tooth discoloration has also been reported in adults. In such cases, the discoloration typically resolves after the medication is discontinued and a dental cleaning is performed. Consult your doctor if you have any concerns.

If you are using birth control pills or other hormone-based contraceptives, be aware that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as a condom, to prevent pregnancy.

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

• Isotretinoin (increased risk of pseudotumor cerebri)

• Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption)
• Iron preparations (decreased minocycline absorption)
• Sucralfate (decreased minocycline absorption)
• Oral contraceptives (potential for decreased efficacy of oral contraceptives, though evidence is weak)
• Warfarin (potentiation of anticoagulant effect, increased INR)
• Penicillins (potential for antagonism of bactericidal effect)

• Methotrexate (may increase methotrexate toxicity)
• Ergot alkaloids (theoretical increased risk of ergotism)
• Live bacterial vaccines (e.g., oral typhoid vaccine - may reduce vaccine efficacy)

• Bismuth subsalicylate (may decrease minocycline absorption)

• Headache (especially severe or persistent)
• Blurred vision or other visual disturbances
• Dizziness or lightheadedness
• Nausea, vomiting, diarrhea
• Rash, itching, hives
• Fever, swollen lymph nodes
• Yellowing of skin or eyes (jaundice)
• Unusual tiredness or weakness
• Joint pain or swelling
• Difficulty swallowing
• Sore throat
• Sunburn-like reaction (photosensitivity)

Minocycline is classified as Pregnancy Category D. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Tetracyclines can cause permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia, and reversible inhibition of bone growth in the fetus.

Minocycline is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, including permanent tooth discoloration and inhibition of bone growth, use during lactation should be avoided if possible. The decision to discontinue nursing or discontinue the drug should take 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 (yellow-gray-brown) and reversible inhibition of bone growth. Use in older children and adolescents should be carefully considered, weighing benefits against risks.

No specific dose adjustment is generally required based on age alone. However, elderly patients may have reduced renal or hepatic function, which could necessitate dose adjustment or closer monitoring. Monitor for adverse effects, especially dizziness and gastrointestinal upset.

• Minocycline ER is often preferred for acne due to its anti-inflammatory properties in addition to its antibacterial action, and the convenience of once-daily dosing.
• Counsel patients extensively on photosensitivity and the importance of sun protection.
• Warn patients about potential for dizziness, especially at the start of therapy, and advise caution with driving or operating machinery.
• Inform patients about the potential for blue-gray skin, nail, or gum discoloration with long-term use, which can be permanent.
• Emphasize taking the medication with a full glass of water and remaining upright for at least 30 minutes to prevent esophageal irritation.
• Advise patients to report any new or worsening headache or visual disturbances immediately, as these could be signs of pseudotumor cerebri.
• Minocycline can cause vestibular side effects (dizziness, vertigo) more commonly than other tetracyclines, especially at higher doses.

• Doxycycline (another tetracycline antibiotic, often used for acne)
• Sarecycline (a newer tetracycline derivative specifically for acne)
• Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
• Topical antibiotics (e.g., clindamycin, erythromycin)
• Benzoyl peroxide
• Oral contraceptives (for hormonal acne in females)
• Spironolactone (for hormonal acne in females)
• Isotretinoin (for severe, recalcitrant nodular 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.