Ximino 135mg ER Capsules
It is used to treat or prevent bacterial infections.It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antibiotic, Tetracycline
Pharmacologic Class
Tetracycline antibiotic; Protein synthesis inhibitor
Pregnancy Category
Category D
FDA Approved
Apr 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ximino is an antibiotic medicine called minocycline, which is used to treat moderate to severe acne. It works by stopping the growth of bacteria that cause acne and by reducing inflammation.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication as directed, even if your symptoms improve.
To establish a routine, take your medication at the same time every day. You can take it with or without food. However, if you experience an upset stomach, taking it with food may help.
It's essential to avoid taking products that contain iron or antacids with aluminum, calcium, or magnesium at the same time as your medication. Consult your doctor or pharmacist for guidance on how to manage these interactions.
Stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. When taking your medication, swallow the tablet whole with a full glass of water. Do not chew, break, or crush the tablet.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Protect it from heat and light. When you no longer need your medication, dispose of it properly.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication as directed, even if your symptoms improve.
To establish a routine, take your medication at the same time every day. You can take it with or without food. However, if you experience an upset stomach, taking it with food may help.
It's essential to avoid taking products that contain iron or antacids with aluminum, calcium, or magnesium at the same time as your medication. Consult your doctor or pharmacist for guidance on how to manage these interactions.
Stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. When taking your medication, swallow the tablet whole with a full glass of water. Do not chew, break, or crush the tablet.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Protect it from heat and light. When you no longer need your medication, dispose of it properly.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take Ximino exactly as prescribed by your doctor, usually once a day.
- You can take Ximino with or without food. Swallow the capsule whole; do not crush, chew, or break it.
- Avoid lying down for at least 30 minutes after taking the medicine to prevent irritation of the esophagus.
- Avoid excessive sun exposure and use sunscreen (SPF 30 or higher) and protective clothing, as minocycline can make your skin more sensitive to the sun.
- If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue your regular schedule. Do not take two doses at once.
- Do not take antacids, iron supplements, or dairy products within 2-3 hours of taking Ximino, as they can interfere with its absorption.
- If you are taking birth control pills, Ximino may make them less effective. Use an additional form of birth control (like condoms) while taking Ximino and for a short time after stopping it.
- Complete the full course of treatment as prescribed, even if your acne improves, to prevent resistance.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
135 mg orally once daily
Dose Range:
45 - 135 mg
Condition-Specific Dosing:
moderate-to-severe non-nodular inflammatory acne vulgaris:
135 mg orally once daily
Pediatric Dosing
Neonatal:
Not established (Contraindicated in children under 8 years)
Infant:
Not established (Contraindicated in children under 8 years)
Child:
Not established (Contraindicated in children under 8 years)
Adolescent:
For patients 12 years and older: 135 mg orally once daily for moderate-to-severe non-nodular inflammatory acne vulgaris.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for increased side effects.
Moderate:
Use with caution; monitor for increased side effects. Consider lower doses or extended intervals if accumulation occurs.
Severe:
Use with caution; monitor for increased side effects. Consider lower doses or extended intervals if accumulation occurs.
Dialysis:
Minocycline is not significantly removed by hemodialysis. Use with caution and monitor.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Use with caution; monitor for increased side effects. Consider lower doses.
Severe:
Use with caution; monitor for increased side effects. Consider lower doses.
Confidence:
Medium
Pharmacology
Mechanism of Action
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 action is bacteriostatic. In acne, it also exhibits anti-inflammatory properties by inhibiting neutrophil chemotaxis and lipase activity of Propionibacterium acnes.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90-100%
Tmax:
Approximately 3-4 hours (for ER formulation)
FoodEffect:
Food (high-fat meal) may decrease Cmax and AUC slightly, but is not considered clinically significant for Ximino. Ximino can be taken with or without food.
Distribution:
Vd:
Approximately 1.2 L/kg
ProteinBinding:
Approximately 70-75%
CnssPenetration:
Yes (achieves therapeutic concentrations in CSF, especially with inflamed meninges)
Elimination:
HalfLife:
Approximately 11-22 hours (for ER formulation)
Clearance:
Not available
ExcretionRoute:
Primarily via renal and fecal routes (biliary excretion)
Unchanged:
Approximately 20-30% renally excreted unchanged
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical effect in acne.
PeakEffect:
Weeks to months for optimal therapeutic effect in acne.
DurationOfAction:
Once daily dosing provides sustained therapeutic levels.
Safety & Warnings
Side Effects
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 medical attention immediately:
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 problems), 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
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)
Stomach pain, cramps, or loose, watery, or bloody stools (if you experience these symptoms, contact your doctor immediately)
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 (such as blurred vision, double vision, or loss of vision)
Thyroid cancer (in rare cases, long-term use of this medication has been associated with thyroid cancer; contact your doctor if you notice:
+ 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 can affect body organs and be life-threatening)
+ Signs of these reactions may 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, fatigue, or weakness
This is not an exhaustive list of 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.
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 medical attention immediately:
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 problems), 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
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)
Stomach pain, cramps, or loose, watery, or bloody stools (if you experience these symptoms, contact your doctor immediately)
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 (such as blurred vision, double vision, or loss of vision)
Thyroid cancer (in rare cases, long-term use of this medication has been associated with thyroid cancer; contact your doctor if you notice:
+ 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 can affect body organs and be life-threatening)
+ Signs of these reactions may 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, fatigue, or weakness
This is not an exhaustive list of 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.
Seek Immediate Medical Attention If You Experience:
- Severe headache, blurred vision, or vision changes (signs of pseudotumor cerebri)
- Yellowing of skin or eyes, dark urine, severe stomach pain, nausea, vomiting (signs of liver problems)
- Severe skin rash, fever, swollen lymph nodes, swelling of the face, or other body parts (signs of DRESS syndrome)
- Severe diarrhea (especially if bloody or watery), stomach cramps, fever (signs of C. difficile infection)
- Dizziness, lightheadedness, or vertigo
- Blue-gray discoloration of skin, nails, or gums (can be permanent)
- Joint pain or swelling
- Unusual tiredness or weakness
Before Using This Medicine
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 pregnant or think you might 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, 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 dosage of any medication without first consulting 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 pregnant or think you might 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, 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 dosage of any medication without first consulting your doctor.
Precautions & Cautions
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 prescribed 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 cause you to sunburn more easily. If you experience unusual sunburn, inform your doctor promptly.
In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the change will be irreversible. Discuss this risk with your doctor. This medication is not approved for use in children under 12 years old, and it is not recommended for children under 8 years old.
Although less common, tooth discoloration has also been reported in adults, but it typically reverses after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.
If you are using birth control pills or other hormone-based contraception, be aware that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as condoms, to prevent pregnancy.
If you are pregnant or become pregnant while taking this medication, it is crucial to contact your doctor immediately, as it may harm the unborn baby.
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 prescribed 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 cause you to sunburn more easily. If you experience unusual sunburn, inform your doctor promptly.
In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the change will be irreversible. Discuss this risk with your doctor. This medication is not approved for use in children under 12 years old, and it is not recommended for children under 8 years old.
Although less common, tooth discoloration has also been reported in adults, but it typically reverses after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.
If you are using birth control pills or other hormone-based contraception, be aware that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as condoms, to prevent pregnancy.
If you are pregnant or become pregnant while taking this medication, it is crucial to contact your doctor immediately, as it may harm the unborn baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Lightheadedness
What to Do:
In case of overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Isotretinoin (increased risk of pseudotumor cerebri)
- Acitretin (increased risk of pseudotumor cerebri)
Major Interactions
- Oral anticoagulants (e.g., Warfarin - may increase anticoagulant effect; monitor INR)
- Penicillins (tetracyclines may interfere with bactericidal action of penicillins; avoid concomitant use)
- Ergot alkaloids (theoretical risk of ergotism, though less documented for minocycline)
- Live bacterial vaccines (e.g., Typhoid vaccine - may reduce efficacy)
Moderate Interactions
- Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption; separate administration by 2-3 hours)
- Iron preparations (decreased minocycline absorption; separate administration by 2-3 hours)
- Bismuth subsalicylate (decreased minocycline absorption; separate administration by 2-3 hours)
- Oral contraceptives (may decrease efficacy of oral contraceptives; advise backup contraception)
- Methoxyflurane (increased risk of nephrotoxicity)
- Digoxin (may increase digoxin levels in some patients)
Minor Interactions
- Dairy products (decreased minocycline absorption; separate administration by 2-3 hours)
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: To establish baseline and identify pre-existing hepatic impairment, as minocycline can cause hepatotoxicity.
Timing: Prior to initiation, especially for long-term therapy or in patients with hepatic risk factors.
Renal function (BUN, creatinine)
Rationale: To establish baseline and identify pre-existing renal impairment, as minocycline is partially renally excreted.
Timing: Prior to initiation, especially for long-term therapy or in patients with renal risk factors.
Routine Monitoring
Clinical response to acne treatment
Frequency: Monthly or as clinically indicated
Target: Reduction in inflammatory lesions
Action Threshold: Lack of improvement after 6-12 weeks may warrant re-evaluation of therapy.
Signs/symptoms of pseudotumor cerebri (headache, blurred vision, papilledema)
Frequency: At each visit
Target: Absence of symptoms
Action Threshold: Presence of symptoms requires immediate discontinuation and ophthalmologic evaluation.
Signs/symptoms of hepatotoxicity (fatigue, nausea, vomiting, dark urine, jaundice)
Frequency: At each visit, or if symptoms arise
Target: Absence of symptoms
Action Threshold: Presence of symptoms requires immediate discontinuation and liver function testing.
Signs/symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome
Frequency: At each visit, especially during first 2-6 weeks of therapy
Target: Absence of fever, rash, lymphadenopathy, organ involvement
Action Threshold: Presence of symptoms requires immediate discontinuation and medical evaluation.
Symptom Monitoring
- Headache
- Dizziness/vertigo
- Nausea
- Vomiting
- Diarrhea
- Photosensitivity (sunburn-like reaction)
- Skin discoloration (blue-gray pigmentation)
- Tooth discoloration (in children)
- Blurred vision
- Tinnitus
- Joint pain/swelling
- Fever
- Rash
- Sore throat
- Unusual bleeding/bruising
Special Patient Groups
Pregnancy
Minocycline is Pregnancy Category D. It can cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus. Avoid use during pregnancy, especially during the second and third trimesters.
Trimester-Specific Risks:
First Trimester:
Potential for skeletal and dental effects, though less pronounced than later trimesters. Risk of congenital malformations not clearly established but generally avoided.
Second Trimester:
High risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth in the fetus.
Third Trimester:
High risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth in the fetus.
Lactation
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. Monitor infant for diarrhea, candidiasis, and potential tooth discoloration. Consider alternative therapies or temporary cessation of breastfeeding.
Infant Risk:
L3 (Moderate risk - possible adverse effects on infant; use only if benefit outweighs risk).
Pediatric Use
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 adolescents (12 years and older) for acne is generally considered acceptable, but careful consideration of risks vs. benefits is warranted.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, elderly patients may have age-related decreases in renal or hepatic function, which may necessitate dose adjustments or closer monitoring for adverse effects.
Clinical Information
Clinical Pearls
- Ximino is an extended-release formulation designed for once-daily dosing, which may improve adherence compared to immediate-release minocycline.
- Counsel patients extensively on photosensitivity and the importance of sun protection.
- Warn patients about potential for dizziness/vertigo, especially at the start of therapy, and advise caution with driving or operating machinery.
- Educate patients about the rare but serious adverse effects like pseudotumor cerebri, DRESS syndrome, and hepatotoxicity, and instruct them to seek immediate medical attention if symptoms occur.
- Minocycline can cause blue-gray skin, nail, or gum discoloration, which can be permanent, especially with long-term use. This is distinct from tooth discoloration.
- While Ximino can be taken with or without food, advise patients to avoid taking it with dairy products, antacids, or iron supplements to ensure optimal absorption.
Alternative Therapies
- Doxycycline (another tetracycline often used for acne)
- Sarecycline (a newer tetracycline specifically for acne, with potentially lower side effect profile)
- Oral contraceptives (for hormonal acne in females)
- Spironolactone (for hormonal acne in females)
- Systemic isotretinoin (for severe, recalcitrant nodular acne)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$800+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand name, may require prior authorization)
General Drug Facts
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, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to 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 seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.