What happens if I overdose Efracea 40mg Modified Release Hard Capsules?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Efracea 40mg Modified Release Hard Capsules suspension:
Store Efracea 40mg Modified Release Hard Capsules suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Efracea 40mg Modified Release Hard Capsules suspension out of the reach of children and away from pets.
Overdose of Efracea 40mg Modified Release Hard Capsules in details
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF Efracea 40mg Modified Release Hard Capsules DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral Efracea 40mg Modified Release Hard Capsules is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours.
In the management of more severe infections (particularly chronic infections of the urinary tract),100 mg every 12 hours is recommended.
For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 lbs the usual adult dose should be used. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. When used in streptococcal infections, therapy should be continued for 10 days.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration.
If gastric irritation occurs, it is recommended that Efracea 40mg Modified Release Hard Capsules be given with food or milk. The absorption of Efracea 40mg Modified Release Hard Capsules is not markedly influenced by simultaneous ingestion of food or milk.
Studies to date have indicated that administration of Efracea 40mg Modified Release Hard Capsules at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice
a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg
by mouth twice a day for 7 days.
Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth twice a day for 7 days.
Syphilis – early: Patients who are allergic to penicillin should be treated with Efracea 40mg Modified Release Hard Capsules 100 mg by mouth twice a day for 2 weeks.
Syphilis of more than one year’s duration: Patients who are allergic to penicillin should be treated with Efracea 40mg Modified Release Hard Capsules 100 mg by mouth twice a day for 4 weeks.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.
For the prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1–2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
Inhalational anthrax (post-exposure):
ADULTS: 100 mg of Efracea 40mg Modified Release Hard Capsules, by mouth, twice a day for 60 days.
CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.
Efracea 40mg Modified Release Hard Capsules hyclate capsules USP equivalent to 50 mg Efracea 40mg Modified Release Hard Capsules (No. 2 opaque white and light blue capsule) in:
Bottles of 60 capsules NDC 54799-536-30 imprinted Mutual 100
Store at 20° to 25°C (68° to 77°F).
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
What should I avoid while taking Efracea 40mg Modified Release Hard Capsules?
Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking Efracea 40mg Modified Release Hard Capsules.
Avoid taking any other antibiotics with Efracea 40mg Modified Release Hard Capsules unless your doctor has told you to.
Avoid exposure to sunlight or tanning beds. Efracea 40mg Modified Release Hard Capsules can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
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 Efracea 40mg Modified Release Hard Capsules and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Efracea 40mg Modified Release Hard Capsules warnings
Tooth Discoloration and Enamel Hypoplasia
The use of Efracea 40mg Modified Release Hard Capsules during tooth development (last half of pregnancy, infancy and childhood 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 drugs of the tetracycline class, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported with drugs of the tetracycline class. Advise the patient of the potential risk to the fetus if Efracea 40mg Modified Release Hard Capsules is used during the second or third trimester of pregnancy.
Inhibition of Bone Growth
The use of Efracea 40mg Modified Release Hard Capsules during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible 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 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. Advise the patient of the potential risk to the fetus if Efracea 40mg Modified Release Hard Capsules is used during the second or third trimester of pregnancy.
Clostridium Difficile Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Efracea 40mg Modified Release Hard Capsules, 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 the use of antibacterial drugs. 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, ongoing use of antibacterial drugs not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Photosensitivity
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with Efracea 40mg Modified Release Hard Capsules, and treatment should be discontinued at the first evidence of skin erythema.
Severe Skin Reactions
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving Efracea 40mg Modified Release Hard Capsules. If severe skin reactions occur, discontinue Efracea 40mg Modified Release Hard Capsules immediately and initiate appropriate therapy.
Jarisch-Herxheimer Reaction
The Jarisch-Herxheimer reaction is a self-limiting systemic reaction that has been reported after the initiation of Efracea 40mg Modified Release Hard Capsules therapy in up to 30% of patients with early Lyme disease. The reaction begins one to two hours after initiation of therapy and disappears within 12 to 24 hours. It is characterized by fever, chills, myalgias, headache, exacerbation of cutaneous lesions, tachycardia, hyperventilation, vasodilation with flushing, and mild hypotension. The pathogenesis of the Jarisch-Herxheimer reaction is unknown, but thought to be due to the release of spirochetal heat-stable pyrogen. Advise the patient of this reaction before starting Efracea 40mg Modified Release Hard Capsules. Administer fluids and antipyretics to alleviate symptoms and duration of the reaction if severe.
Intracranial Hypertension
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Efracea 40mg Modified Release Hard Capsules. Clinical manifestations of IH 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 greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and Efracea 40mg Modified Release Hard Capsules should be avoided because isotretinoin is also known to cause pseudotumor cerebri.
Although IH may improve after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.
Antianabolic Action
The antianabolic action of the tetracyclines, including Efracea 40mg Modified Release Hard Capsules may cause an increase in BUN. Studies to date indicate that this does not occur with the use of Efracea 40mg Modified Release Hard Capsules in patients with renal impairment.
Development of Drug Resistant Bacteria
Prescribing Efracea 40mg Modified Release Hard Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
Potential for Microbial Overgrowth
As with other antibacterial drugs, use of Efracea 40mg Modified Release Hard Capsules may result in overgrowth of non-susceptible organisms, including fungi. If such infections occur, discontinue Efracea 40mg Modified Release Hard Capsules and institute appropriate therapy.
What should I discuss with my healthcare provider before taking Efracea 40mg Modified Release Hard Capsules?
Some medical conditions may interact with Efracea 40mg Modified Release Hard Capsules hyclate. 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 diarrhea, a history of lupus, or the blood disease porphyria
Some MEDICINES MAY INTERACT with Efracea 40mg Modified Release Hard Capsules hyclate. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), iron, or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Efracea 40mg Modified Release Hard Capsules hyclate's effectiveness
- Acitretin, anticoagulants (eg, warfarin), digoxin, isotretinoin, methotrexate, or methoxyflurane because the side effects and toxic effects may be increased by Efracea 40mg Modified Release Hard Capsules hyclate
- Live oral typhoid vaccine, hormonal birth control (eg, birth control pills), or penicillins (eg, amoxicillin) because their effectiveness may be decreased by Efracea 40mg Modified Release Hard Capsules hyclate
This may not be a complete list of all interactions that may occur. Ask your health care provider if Efracea 40mg Modified Release Hard Capsules hyclate 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.
Efracea 40mg Modified Release Hard Capsules precautions
While no overgrowth by opportunistic microorganisms such as yeast were noted during clinical studies, as with other antimicrobials, Efracea 40mg Modified Release Hard Capsules® (Efracea 40mg Modified Release Hard Capsules hyclate) therapy may result in overgrowth of nonsusceptible microorganisms including fungi.
The use of tetracyclines may increase the incidence of vaginal candidiasis.
Efracea 40mg Modified Release Hard Capsules® (Efracea 40mg Modified Release Hard Capsules hyclate) should be used with caution in patients with a history or predisposition to oral candidiasis. The safety and effectiveness of Efracea 40mg Modified Release Hard Capsules® (Efracea 40mg Modified Release Hard Capsules hyclate) has not been establishedfor the treatment of periodontitis in patients with coexistant oral candidiasis.
If superinfection is suspected, appropriate measures should be taken.
Laboratory Tests
In long term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Efracea 40mg Modified Release Hard Capsules hyclate was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to Efracea 40mg Modified Release Hard Capsules approximately nine times that observed in female humans that used Efracea 40mg Modified Release Hard Capsules (Efracea 40mg Modified Release Hard Capsules hyclate) (exposure comparison based upon AUC values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/day, or in either gender at the other dosages studied. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors).
Efracea 40mg Modified Release Hard Capsules hyclate demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that Efracea 40mg Modified Release Hard Capsules hyclate is a weak clastogen.
Oral administration of Efracea 40mg Modified Release Hard Capsules hyclate to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Efracea 40mg Modified Release Hard Capsules hyclate induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 10 times the amount of Efracea 40mg Modified Release Hard Capsules hyclate contained in the recommended daily dose of Efracea 40mg Modified Release Hard Capsules® (Efracea 40mg Modified Release Hard Capsules hyclate) for a 60 kg human when compared on the basis of body surface area estimates (mg/m²). Although Efracea 40mg Modified Release Hard Capsules impairs the fertility of rats when administered at sufficient dosage, the effect of Efracea 40mg Modified Release Hard Capsules® (Efracea 40mg Modified Release Hard Capsules hyclate) on human fertility is unknown.
Pregnancy
Teratogenic Effects
Pregnancy Category D.. Results from animal studies indicate that Efracea 40mg Modified Release Hard Capsules crosses the placenta and is found in fetal tissues.
Nonteratogenic effects
.
Labor and Delivery
The effect of tetracyclines on labor and delivery is unknown.
Nursing Mothers
Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Efracea 40mg Modified Release Hard Capsules, the use of Efracea 40mg Modified Release Hard Capsules® (Efracea 40mg Modified Release Hard Capsules hyclate) in nursing mothers is contraindicated..
Pediatric Use
The use of Efracea 40mg Modified Release Hard Capsules® (Efracea 40mg Modified Release Hard Capsules hyclate) in infancy and childhood is contraindicated.
What happens if I miss a dose of Efracea 40mg Modified Release Hard Capsules?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "DOXYCYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "doxycycline". http://www.drugbank.ca/drugs/DB00254 (accessed September 17, 2018).
- MeSH. "Antimalarials". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
