Adoxa 150mg Capsules

Doxycycline 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 ribosomal acceptor site. This action prevents the addition of new amino acids to the growing peptide chain, leading to bacteriostasis. It also has anti-inflammatory properties at sub-antimicrobial doses.

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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Chest pain or pressure, or a fast heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Throat irritation
Trouble swallowing
Muscle or joint pain
Rapid breathing
Flushing
Severe dizziness or fainting
Changes in skin color
Vaginal itching or discharge
Diarrhea, especially if it is severe, bloody, or watery (see below for more information on diarrhea)

Important Information About Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or severe diarrhea (especially if it is bloody or watery), contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.

Raised Pressure in the Brain

This medication can cause increased pressure in the brain, which may lead to loss of vision. In most cases, this condition resolves once the medication is stopped. However, in some cases, vision loss may be permanent. If you experience a headache or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor right away.

Other Side Effects

Like all medications, this drug can cause side effects. Many people do not experience any side effects or only have mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach
Vomiting
* Decreased appetite

Reporting Side Effects

This is not an exhaustive list of all possible side effects. If you have 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 symptoms you experienced.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
* If you are breast-feeding or plan to breast-feed, as you may need to avoid doing so while taking this medication.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dosage 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. If you are on long-term treatment with this drug, your doctor may recommend regular blood tests to monitor your condition.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your 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.

You may be more susceptible to sunburn while taking this medication, so take necessary precautions when exposed to the sun. If you experience easy sunburning, inform your doctor promptly.

This drug can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that may affect internal organs. These reactions can be life-threatening. Seek immediate medical attention if you exhibit symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

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

In children under 8 years old, this medication may cause permanent tooth discoloration (yellow-gray brown) or affect tooth development. Additionally, bone growth may be impacted in these individuals. If you have concerns, discuss them with your doctor. It is generally recommended that children under 8 years old not take this medication, but there may be exceptions. Consult with your doctor to determine the best course of action.

Tooth discoloration has also been reported in adults, but this condition may be reversible after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.

If you are pregnant or become pregnant while taking this medication, you may be at risk of harming your unborn baby. Immediately contact your doctor if you are pregnant or suspect you may be pregnant.

• Isotretinoin (and other oral retinoids) - increased risk of pseudotumor cerebri (benign intracranial hypertension)

• Antacids (containing aluminum, calcium, magnesium) - decreased doxycycline absorption
• Iron preparations - decreased doxycycline absorption
• Bismuth subsalicylate - decreased doxycycline absorption
• Barbiturates (e.g., phenobarbital) - decreased doxycycline half-life
• Carbamazepine - decreased doxycycline half-life
• Phenytoin - decreased doxycycline half-life
• Warfarin - increased anticoagulant effect (monitor INR)
• Penicillins - may interfere with bactericidal action of penicillin (avoid concomitant use for serious infections)

• Oral contraceptives - may reduce efficacy of oral contraceptives (use alternative birth control)
• Methotrexate - increased methotrexate toxicity (monitor for adverse effects)
• Cholestyramine - decreased doxycycline absorption
• Ergot alkaloids - theoretical increased risk of ergotism (monitor)

• Digoxin - may increase digoxin levels (monitor)

• Severe headache, blurred vision, diplopia, vision loss (signs of pseudotumor cerebri)
• Severe diarrhea, abdominal pain, fever (signs of C. difficile infection)
• Yellowing of skin or eyes, dark urine, persistent nausea/vomiting (signs of liver dysfunction)
• Severe skin rash, blistering, peeling (signs of severe cutaneous adverse reactions)
• Sunburn-like reaction after minimal sun exposure (photosensitivity)

Contraindicated during the second and third trimesters of pregnancy due to the risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the fetus. Use in the first trimester should be avoided unless the potential benefit outweighs the risk.

Doxycycline is excreted into breast milk. While absorption by the infant is generally low due to chelation with calcium in milk, there is a theoretical risk of tooth discoloration and inhibition of bone growth. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Monitor infant for diarrhea, candidiasis, and potential tooth discoloration. Short-term use may be acceptable; long-term or repeated use should be avoided.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia, as well as reversible inhibition of bone growth. Use in children ≥ 8 years should be carefully considered and only when other antibiotics are not suitable.

No specific dose adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects such as gastrointestinal irritation and photosensitivity. Monitor renal and hepatic function if pre-existing impairment is present.

• Doxycycline is unique among tetracyclines for its primary non-renal excretion, making it a preferred choice for patients with renal impairment.
• Always advise patients to take with a full glass of water and remain upright for at least 30 minutes to prevent esophageal ulceration, a common and painful side effect.
• Emphasize strict sun protection due to high photosensitivity risk.
• Beyond its antibacterial properties, doxycycline is widely used for its anti-inflammatory effects at sub-antimicrobial doses (e.g., for rosacea and acne).
• The 150mg strength (Adoxa) is often used for more severe infections or for once-daily dosing regimens where 100mg might be insufficient or 200mg is too high.

• Other tetracyclines (e.g., minocycline, tetracycline)
• Macrolides (e.g., azithromycin, erythromycin) for respiratory or atypical infections
• Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for certain infections
• Beta-lactam antibiotics (e.g., penicillins, cephalosporins) depending on the specific bacterial infection
• For acne/rosacea: Topical retinoids, topical antibiotics, oral isotretinoin (for severe acne), other oral antibiotics (e.g., azithromycin, erythromycin)

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets; consult with your pharmacist to determine if this applies to your prescription. If you have any questions or concerns about your medication, 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.