Asolmicina Overdose

• Overdose of Asolmicina in details
• Asolmicina warnings
• Asolmicina precautions
• Asolmicina reviews

What happens if I overdose Asolmicina?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Asolmicina extended-release tablets:

Store Asolmicina extended-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Asolmicina extended-release tablets out of the reach of children and away from pets.

Overdose of Asolmicina in details

The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting.

No specific antidote for Asolmicina hydrochloride is known.

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures.

Asolmicina hydrochloride is not removed in significant quantities by hemodialysis or peritoneal dialysis.

What should I avoid while taking Asolmicina?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Asolmicina and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Asolmicina can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking Asolmicina.

Asolmicina may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Asolmicina warnings

Teratogenic Effects

Avoid Asolmicina use during pregnancy.

Asolmicina, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman. Asolmicina, like other tetracycline-class drugs, may cause permanent discoloration of the teeth and inhibit bone growth when administered during pregnancy. Based on animal data, tetracyclines cross the placenta, are found in fetal tissues, and can cause skeletal malformation and retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy. If Asolmicina is used during pregnancy, advise the patient of the potential risk to the fetus and discontinue treatment.

Tooth Discoloration

The use of tetracycline class drugs during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the tetracycline but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use of tetracycline drugs is not recommended during tooth development.

The safety and effectiveness of Asolmicina have not been established in pediatric patients less than 12 years of age.

Inhibition of Bone Growth

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. The safety and effectiveness of Asolmicina have not been established in patients less than 12 years of age.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy.

5.4 Pseudomembranous Colitis

Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including Asolmicina, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.5 Hepatotoxicity

Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with Asolmicina use in the treatment of acne.

5.6 Metabolic Effects

The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

5.7 Central Nervous System Effects

Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with Asolmicina therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on Asolmicina therapy. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued.

5.8 Intracranial Hypertension

Intracranial hypertension has been associated with the use of tetracycline-class drugs including Asolmicina. Clinical manifestations of intracranial hypertension include headache, blurred vision, diplopia and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at a greater risk for developing intracranial hypertension. Concomitant use of isotretinoin and tetracycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension.

Although intracranial hypertension typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Because intracranial pressure can remain elevated for weeks after drug cessation, patients should be monitored until they stabilize.

5.9 Autoimmune Syndromes

Tetracyclines have been associated with the development of autoimmune syndromes. The long- term use of Asolmicina in the treatment of acne has been associated with drug-induced lupus- like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after Asolmicina use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, immediately discontinue the use of all tetracycline-class drugs, including Asolmicina.

5.10 Photosensitivity

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines; this reaction has been reported less frequently with Asolmicina. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Asolmicina. If patients need to be outdoors while using Asolmicina, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.

5.11 Serious Skin/Hypersensitivity Reaction

Cases of anaphylaxis, serious skin reactions (e.g. Stevens Johnson syndrome), erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with Asolmicina use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, discontinue Asolmicina immediately.

5.12 Tissue Hyperpigmentation

Tetracyclines are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as pigmentation over sites of scars or injury.

5.13 Development of Drug-Resistant Bacteria

Asolmicina has not been evaluated in the treatment of infections.

Bacterial resistance to the tetracyclines may develop in patients using Asolmicina. Because of the potential for drug-resistant bacteria to develop during the use of Asolmicina, it should be used only as indicated.

5.14 Superinfection

Use of Asolmicina may result in overgrowth of nonsusceptible organisms, including fungi. If super infection occurs, discontinue Asolmicina and institute appropriate therapy.

5.15 Laboratory Monitoring

Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.

What should I discuss with my healthcare provider before taking Asolmicina?

Some medical conditions may interact with Asolmicina microspheres. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of oral fungal infections
• if you have a weakened immune system, an autoimmune disorder (eg, lupus), diabetes, or HIV, or if you are receiving chemotherapy or radiation treatment

Some MEDICINES MAY INTERACT with Asolmicina microspheres. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aluminum salts (eg, carbonate) or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Asolmicina microspheres's effectiveness
• Acitretin, anticoagulants (eg, warfarin), digoxin, ergot alkaloids and derivatives (eg, ergotamine), insulin, isotretinoin, methotrexate, methoxyflurane, or theophyllines because the risk of their side effects may be increased by Asolmicina microspheres
• Live oral typhoid vaccine, oral contraceptives (birth control pills), or penicillins because their effectiveness may be decreased by Asolmicina microspheres

This may not be a complete list of all interactions that may occur. Ask your health care provider if Asolmicina microspheres may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Asolmicina precautions

General

Safety of Asolmicina® beyond 12 weeks of use has not been established.

As with other antibiotic preparations, use of Asolmicina® may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.

Bacterial resistance to the tetracyclines may develop in patients using Asolmicina,® therefore the susceptibility of bacteria associated with infection should be considered in selecting antimicrobial therapy. Because of the potential for drug-resistant bacteria to develop during the use of Asolmicina,® it should be used only as indicated.

Autoimmune Syndromes

Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of Asolmicina in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after Asolmicina use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.

Serious Skin/Hypersensitivity Reaction

Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with Asolmicina use in treatment of acne.

Tissue Hyperpigmentation

Tetracycline class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

Information for Patients

1. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including Asolmicina. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Asolmicina. If patients need to be outdoors while using Asolmicina, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of skin erythema.
2. Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on Asolmicina therapy. Patients should also be cautioned about seeking medical help for headaches or blurred vision.
3. Concurrent use of tetracycline may render oral contraceptives less effective.
4. Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class antibiotics, including Asolmicina. Symptoms may be manifested by arthralgia, fever, rash and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help.
5. Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from Asolmicina therapy.
6. Take Asolmicina® exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.
7. Asolmicina® should not be used by pregnant women or women attempting to conceive a child.
8. It is recommended that Asolmicina® not be used by men who are attempting to father a child.

Laboratory Tests

Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.

Drug Interactions

1. Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

2. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

3. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

4. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

5. In a multi-center study to evaluate the effect of Asolmicina® on low dose oral contraceptives, hormone levels over one menstrual cycle with and without Asolmicina® 1 mg/kg once-daily were measured.

Based on the results of this trial, Asolmicina-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, can not be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with Asolmicina.

Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Carcinogenesis, Mutagenesis & Impairment of Fertility

Carcinogenesis

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Asolmicina. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.

Mutagenesis

Asolmicina was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Asolmicina was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Impairment of Fertility

Male and female reproductive performance in rats was unaffected by oral doses of Asolmicina of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to Asolmicina observed in patients as a result of use of Asolmicina®). However, oral administration of 100 or 300 mg/kg/day of Asolmicina to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to Asolmicina observed in patients as a result of use of Asolmicina®) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormailities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

Limited human studies suggest that Asolmicina may have a deleterious effect on spermatogenesis.

Asolmicina® should not be used by individuals of either gender who are attempting to conceive a child.

Pregnancy

Teratogenic Effects

Pregnancy category D

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of Asolmicina in pregnant women. Asolmicina, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported with Asolmicina use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established.

Asolmicina induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to Asolmicina observed in patients as a result of use of Asolmicina®). Reduced mean fetal body weight was observed in studies in which Asolmicina was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to Asolmicina as that observed in patients who use Asolmicina®).

Asolmicina® should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately.

Nursing Mothers

Tetracycline-class antibiotics are excreted in human milk. Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Asolmicina® is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established.

Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration.

Geriatric Use

Clinical studies of Asolmicina® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

What happens if I miss a dose of Asolmicina?

Call your dentist for instructions if you miss an appointment for a repeat treatment with Asolmicina mucous membrane.

References

1. DrugBank. "minocycline". http://www.drugbank.ca/drugs/DB01017 (accessed September 17, 2018).
2. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology