Active ingredients: Doxycycline (doxycycline hyclate)
Bassado 100 mg tablets
Why is Bassado used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antibacterials for systemic use
THERAPEUTIC INDICATIONS
Infections with Gram-positive and Gram-negative germs sensitive to tetracyclines.
Contraindications When Bassado should not be used
Hypersensitivity to the active substance, to tetracyclines or to any of the excipients listed in the "Composition" section.
Obstructive disorders of the esophagus, such as narrowing or achalasia.
The product is contraindicated in pregnant and lactating women and children up to 12 years of age (see section "Special warnings").
Precautions for use What you need to know before taking Bassado
It is recommended that all patients taking doxycycline:
- Avoid excessive exposure to sunlight or artificial UV rays during treatment, and discontinue therapy if phototoxic reactions (eg skin rashes) occur. Use partial or full sunscreen.
- Take doxycycline with plenty of water to reduce the risk of esophageal irritation and ulcers.
- Know that the absorption of tetracyclines is reduced when bismuth subsalicylate is also taken.
- Knowing that doxycycline therapy may increase the incidence of vaginal candidiasis.
Hepatic impairment
The administration of doxycycline in high doses and for periods of time longer than two weeks can cause disturbances in liver function which should therefore be monitored, discontinuing the treatment in case of abnormal reactions.
Renal impairment
The excretion of doxycycline is not modified in subjects with impaired renal function; however, in such patients it is advisable to proceed with caution, possibly reducing the amount of doses.
In subjects with renal insufficiency, even normal doses of tetracycline can cause an accumulation in the circulation with possible liver damage; in these cases it is necessary to adopt the dosage according to the degree of renal function, resorting, if necessary, to checks of blood levels (which should never exceed 15 mcg / ml) and liver function. It should also be kept in mind that tetracyclines exert an "antianabolic action which can aggravate states of renal insufficiency.
Esophagitis
Cases of oesophagitis and oesophageal ulcers, sometimes severe, have been reported. Patients are advised to take the drug with plenty of water, even during meals, to remain upright for at least one hour after taking the medicine and not to take the medicine before bedtime.
If symptoms such as difficulty in swallowing or retrosternal pain occur during therapy, the drug should be immediately interrupted and evaluated with the attending physician for the opportunity to carry out instrumental investigations.
In the treatment of patients suffering from established esophageal reflux, other therapeutic alternatives should also be considered.
Gonococcal infections
In the treatment of gonococcal infections, attention should be paid to the risk of masking the manifestations of coexisting syphilis; in these cases it is advisable to carry out serological checks for at least 4 months.
Myasthenia Grave
Doxycycline should be used with caution in patients with myasthenia gravis.
Long-term treatment cycles require periodic checks of blood count and renal and hepatic function.
Interactions Which drugs or foods can modify the effect of Bassado
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Oral absorption of tetracyclines is reduced by:
- antacid preparations containing aluminum, calcium and magnesium,
- dairy or milk based foods,
- products containing iron salts and preparations containing zinc and bismuth orally.
It is therefore advisable to avoid simultaneous intakes and to distance the administration of the aforementioned products from that of tetracyclines (at least 2 hours, if possible). There have been rare reports in the literature of increased plasma concentrations of lithium, methotrexate, digoxin and ergot derivatives following concomitant administration of tetracyclines.
Oral anticoagulants
Prolongation of prothrombin time has been reported in patients taking warfarin and doxycycline. Since tetracyclines can depress prothrombin activity, it may be necessary to reduce the dosages of anticoagulants taken at the same time.
Penicillins
The association of tetracyclines, including doxycycline, with penicillins should be avoided, due to the possible occurrence of interference between their respective antibacterial activities.
Anticonvulsants
Barbiturates (phenobarbital, primidone), carbamazepine and phenytoin reduce the half-life of doxycycline.
Alcoholic beverages
The half-life of doxycycline can be shortened by the simultaneous intake of alcoholic beverages.
Oral contraceptives
Taking tetracyclines may decrease the effectiveness of oral contraceptive treatments. Some cases of pregnancy or intermenstrual blood loss have been attributed to the concomitant use of tetracyclines with oral contraceptives.
Cyclosporine
Doxycycline may increase cyclosporine plasma concentrations. Any co-administration, therefore, must be carefully monitored.
Interactions related to other medicinal products
Concomitant use not recommended:
Systemic retinoids
Co-administration with tetracyclines increases the risk of developing benign intracranial hypertension (a reversible increase in intracranial pressure).
Methoxyflurane
Co-administration with tetracyclines has resulted in fatal case reports of nephrotoxicity.
Interactions with laboratory investigations
False increases in urinary catecholamine levels may occur due to interference with the fluorescence test.
Warnings It is important to know that:
Superinfections
As with other antibiotics, treatment with tetracyclines can result in superinfections with resistant bacterial agents or fungi. The possibility of resistant staphylococcal enterocolitis should be kept in mind. Constant monitoring of the patient is essential. If a resistant organism appears, treatment should be discontinued and appropriate therapy instituted.
Clostridium difficile associated diarrhea (CDAD)
Cases of Clostridium difficile associated diarrhea (CDAD) have been reported with the use of nearly all antibiotics, including doxycycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibiotics alters normal flora. colon and leads to an overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of diarrhea. Strains of C. difficile that produce excess toxins cause increased morbidity and mortality rates, as these infections are typically refractory to antibacterial therapy and often require colectomy. The possibility of C. difficile-associated diarrhea should be considered in all patients who present with diarrhea following antibiotic treatment. A careful medical history is also required as cases of C. difficile associated diarrhea have been reported even more than two months after antibiotic administration.
Pediatric population
Doxycycline, like other tetracyclines, gives rise to a stable calcium complex in the forming bone tissue. A reduction in fibula growth rate was observed in premature babies who were given oral tetracycline at a dose of 25 mg / kg every six hours. This reaction proved to be reversible upon discontinuation of treatment.
The use of tetracyclines during the period of tooth formation (second half of pregnancy, neonatal period and early childhood up to 12 years of age) can cause permanent dental pigmentation (yellow-brown); this occurs mainly after use prolonged use of these antibiotics, but has also been observed after short but repeated treatment periods. Enamel hypoplasia has also been reported, so doxycycline should not be given to this patient group unless other drugs are available or may be ineffective or contraindicated.
General
Cases of domed fontanelles in neonates and benign intracranial hypertension in adults have been reported with full dose intake. These effects resolved rapidly upon discontinuation of treatment.
Pregnancy and breastfeeding:
No data are available on the use of doxycycline during pregnancy. Use in pregnant women is contraindicated (see sections "Contraindications" and "Special warnings": Pediatric population).
Doxycycline should not be taken during lactation as it is present in the breast milk of lactating women with any tetracycline, including doxycycline.
Important information about some of the ingredients of Bassado
The medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Driving and using machines
There is no evidence to indicate effects of doxycycline on the ability to drive or use machines.
Dosage and method of use How to use Bassado: Dosage
Two tablets at once on the first day of treatment, one tablet on the following days. In case of severe infections, strictly follow the doctor's instructions.
In all group A beta hemolytic streptococcal infections, treatment should last no less than ten days.
In order to obtain maximum therapeutic safety, it will be advisable, in any case, to carry out an antibiogram to ensure that the isolated microorganism responsible for the infection to be treated is sensitive to the action of the tetracyclines.
Each dose should be taken during meals with a "large amount of" water (one full glass). The patient should take the medicine in an upright position at least one "hour before bedtime (see section" Precautions for use ").
The duration of therapy will depend on the evolution of the infection; however, it is advisable not to suspend therapy until after the fever and clinical symptoms have disappeared.
Overdose What to do if you have taken too much Bassado
In case of accidental intake of an excessive dose of the medicine, notify your doctor immediately or go to the nearest hospital.
In case of overdose, practice gastrolusis. Hemodialysis is not indicated in the event of an overdose as it does not change the residence time of the drug in the blood.
For any appropriate clarification on the use of the medicine, contact your doctor or pharmacist.
Side Effects What are the side effects of Bassado
Like all medicines, BASSADO can cause side effects, although not everybody gets them.
The following side effects have been observed in patients taking tetracyclines, including doxycycline
CIOMS III frequency categories: Very Common ≥ 1/10 (≥ 10%), Common ≥ 1/100 a
Compliance with the instructions contained in this leaflet reduces the risk of undesirable effects.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package. The expiry date refers to the product in intact packaging, correctly stored.
WARNING: do not use the medicine after the expiry date shown on the package.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN.
COMPOSITION
Each tablet contains:
Active ingredient: doxycycline hyclate 115.4 mg, equivalent to doxycycline anhydrous base 100 mg
Excipients: starch, sodium laurilsulfate, lactose, alginic acid, magnesium stearate
PHARMACEUTICAL FORM AND CONTENT
Tablets
Pack of 10 tablets of 100 mg
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BASSADO 100 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Active principle: doxycycline hyclate 115.4 mg corresponding to doxycycline anhydrous base 100 mg.
Excipients with known effects: lactose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Infections with Gram-positive and Gram-negative germs sensitive to tetracyclines.
04.2 Posology and method of administration
Dosage
Two tablets at once on the first day of treatment; one tablet in the following days.
In case of severe infections, strictly follow the doctor's instructions.
In all group A beta hemolytic streptococcal infections, treatment should last no less than ten days.
In order to obtain maximum therapeutic safety, it will be advisable, in any case, to carry out an antibiogram to ensure that the isolated microgranism responsible for the infection to be treated is sensitive to the action of the tetracyclines.
Method of administration
Each dose should be taken during meals with a "large amount of" water (one full glass).
The patient should be advised to take the medicine in an upright position and not to lie down for at least one hour after taking the medicine.
The duration of therapy will depend on the evolution of the infection; however, it is advisable not to suspend therapy until after the fever and clinical symptoms have disappeared.
04.3 Contraindications
• Hypersensitivity to the active substance, to tetracyclines or to any of the excipients listed in section 6.1.
• Obstructive disorders of the esophagus, such as narrowing or achalasia.
• The product is contraindicated in pregnant and lactating women and children up to 12 years of age (see sections 4.4 and 4.6).
04.4 Special warnings and appropriate precautions for use
Pediatric population
Doxycycline, like other tetracyclines, gives rise to a stable calcium complex in the forming bone tissue. A reduction in fibula growth rate was observed in premature babies who were given oral tetracycline at a dose of 25 mg / kg every six hours. This reaction proved to be reversible upon discontinuation of treatment.
The use of tetracyclines during the period of tooth formation (second half of pregnancy, neonatal period and early childhood up to 12 years of age) can cause permanent dental pigmentation (yellow-brown); this occurs mainly after use protracted of these antibiotics but has also been observed after short but repeated treatment periods. Enamel hypoplasia has also been reported, so doxycycline should not be given to this patient group unless other drugs are available or may be ineffective or contraindicated.
General
Cases of domed fontanelles in neonates and benign intracranial hypertension in adults have been reported with full dose intake. These effects resolved rapidly upon discontinuation of treatment.
Diarrhea associated with Clostridium difficile (CDAD)
Cases of Clostridium difficile associated diarrhea (CDAD) have been reported with the use of nearly all antibiotics, including doxycycline, and can range in severity from mild diarrhea to fatal colitis. Treatment with antibiotics alters normal flora. colon and leads to overgrowth of C.hard.
The C. difficult produces toxins A and B which contribute to the development of diarrhea. The strains of C. hard that produce excess toxins cause increased morbidity and mortality rates, as these infections are typically refractory to antibacterial therapy and often require a colectomy.
The possibility of associated diarrhea should be considered C. difficult in all patients who present with diarrhea following antibiotic treatment. A careful medical history is also required since cases of diarrhea associated with C. difficult they have also been reported over two months after antibiotic administration.
Superinfections
As with other antibiotics, treatment with tetracyclines can result in superinfections with resistant bacterial agents or fungi. The possibility of resistant staphylococcal enterocolitis should be considered. Constant monitoring of the patient is essential. If a resistant organism appears, treatment should be discontinued and appropriate therapy instituted.
Esophagitis
Cases of oesophagitis and oesophageal ulcers, sometimes severe, have been reported. Patients should be advised to take the drug with plenty of water, including with meals, to remain upright for at least one hour after taking the medicine and not to take the medicine before bedtime.
If symptoms such as dysphagia or retrosternal pain occur, the drug should be stopped immediately and the opportunity to carry out instrumental investigations should be considered.
In the treatment of patients suffering from established esophageal reflux, other therapeutic alternatives should also be considered.
Photosensitization
Reactions of photosensitivity, which are evidenced by an exaggerated skin reactivity to sunlight and ultraviolet rays, can occur during treatment in predisposed subjects: it is advisable to keep this possibility in mind by avoiding direct exposure to sunlight and stopping the treatment as soon as erythema appears. cutaneous.
Hepatic impairment
The administration of doxycycline in high doses and for periods of time longer than two weeks can cause disturbances in liver function which should therefore be monitored, discontinuing the treatment in case of abnormal reactions.
Renal impairment
The excretion of doxycycline is not modified in subjects with impaired renal function; however, in such patients it is advisable to proceed with caution, possibly reducing the amount of doses.
In subjects with renal insufficiency, even normal doses of tetracyclines can cause an accumulation in the circulation with possible liver damage; in these cases it is necessary to adapt the posology to the degree of renal function, resorting, if necessary, to checks on blood levels (which should never exceed 15 mcg / ml) and liver function.
It should also be kept in mind that tetracyclines exert an "antianabolic action which can aggravate states of renal insufficiency.
Gonococcal infections
In the treatment of gonococcal infections, attention must be paid to the risk of masking the manifestations of coexisting syphilis: in these cases, serological checks should be carried out for at least 4 months.
Long-term treatment cycles require periodic checks of blood count and liver and kidney function.
Myasthenia Grave
Doxycycline should be used with caution in patients with myasthenia gravis (see section 4.8).
Vaginal candidiasis
The use of doxycycline may increase the incidence of vaginal candidiasis.
The medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Oral absorption of tetracyclines is reduced by:
• antacid preparations containing aluminum, calcium and magnesium,
• foods based on milk or dairy products,
• products containing iron salts, and preparations containing zinc and bismuth orally
It is therefore advisable to avoid simultaneous intakes and to distance the administration of the aforementioned products from that of tetracyclines (at least 2 hours, if possible).
There have been rare reports in the literature of increased plasma concentrations of lithium, methotrexate, digoxin and ergot derivatives following concomitant administration of tetracyclines.
Oral anticoagulants
Prolongation of prothrombin time has been reported in patients taking warfarin and doxycycline. Since tetracyclines can depress prothrombin activity, it may be necessary to reduce the dosages of anticoagulants taken at the same time.
Penicillins
The association of tetracyclines, including doxycycline, with penicillins should be avoided, due to the possible occurrence of interference between their respective antibacterial activities.
Anticonvulsants
Barbiturates (phenobarbital, primidone), carbamazepine and phenytoin reduce the half-life of doxycycline.
Alcoholic beverages
The half-life of doxycycline can be shortened by the simultaneous intake of alcoholic beverages.
Oral contraceptives
Taking tetracyclines may decrease the effectiveness of oral contraceptive treatments. Some cases of pregnancy or intermenstrual blood loss have been attributed to the concomitant use of tetracyclines with oral contraceptives.
Cyclosporine:
doxycycline may increase cyclosporine plasma concentrations. Any co-administration, therefore, must be carefully monitored.
Interactions related to other medicinal products
Concomitant use not recommended:
Systemic retinoids:
co-administration with tetracyclines increases the risk of developing benign intracranial hypertension (a reversible increase in intracranial pressure).
Methoxyflurane:
co-administration with tetracyclines has resulted in fatal case reports of nephrotoxicity.
Interactions with laboratory investigations
False increases in urinary catecholamine levels may occur due to interference with the fluorescence test.
04.6 Pregnancy and lactation
Pregnancy
No data are available on the use of doxycycline during pregnancy. Use in pregnant women is contraindicated (see sections 4.3 and 4.4, Pediatric population).
Animal studies have shown that tetracyclines cross the placental barrier, reach fetal tissues and can have harmful effects on the developing fetus (often associated with delayed skeletal development).Signs of embryotoxicity were also noted in animals treated during the early stages of pregnancy.
Feeding time
Doxycycline should not be taken during lactation as it is present in the breast milk of lactating women with any tetracycline, including doxycycline (see section 4.3).
04.7 Effects on ability to drive and use machines
There is no evidence to indicate effects of doxycycline on the ability to drive or use machines.
04.8 Undesirable effects
The following undesirable effects have been observed in patients taking tetracyclines, including doxycycline.
CIOMS III frequency categories: very common ≥ 1/10 (≥ 10%), common ≥ 1/100 a
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
In case of overdose, practice gastrolusis. Hemodialysis is not indicated in case of overdose as it does not change the serum half-life of the product.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antibacterial for systemic use.
ATC code: J01AA02.
Doxycycline is a broad spectrum antibiotic, active at low concentration both on gram-positive and some gram-negative germs as well as on rickettsiae, mycoplasma, chlamydia, some typical mycobacteria and amoebae. Doxycycline differs from other tetracyclines for its high intestinal absorption and for the remarkable duration of its therapeutic action.
05.2 Pharmacokinetic properties
Bassado is an antibiotic with a broad spectrum of action structurally similar to oxytetracycline from which it differs for the different pharmacokinetics. Bassado has a much longer half-life, is partly reabsorbed by the renal tubules, so that it can be administered in low doses.
The absorption of doxycycline, after oral administration, is almost complete and is approximately 2-4 times higher than that of the other tetracyclines; administration during meals does not change the degree of absorption. One hour after administration, blood levels are reached. therapeutically active, peaking between the second and fourth hours. In the adult, after oral intake of a dose of 200 mg, a blood peak greater than 3 mcg / ml was observed, a residual concentration greater than 1 mcg / ml after 24 hours, a blood half-life of 16-22 hours. The protein binding varies between 82% and 93% (weak binding). About 60% of the administered dose is eliminated in the faeces, the remainder in the urine. In case of renal insufficiency renal elimination decreases and the fecal one increases. Hemodialysis does not change the half-life.
05.3 Preclinical safety data
The LD50 in mice was equal to 1650 mg / kg orally and 490 mg / kg by the endoperitoneal route; in the rat at 2545 mg / kg orally and at 360 mg / kg by the endoperitoneal route. In chronic administration at a dose of 100 mg / kg / day per os in the rat, Bassado did not show any toxic effect.
Furthermore, no teratogenic effects were found in rats and rabbits.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Starch, sodium lauryl sulfate, lactose, alginic acid, magnesium stearate.
06.2 Incompatibility
None known.
06.3 Period of validity
21 months.
06.4 Special precautions for storage
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
10 tablets packed in aluminum / PVC blisters.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Pfizer Italia S.r.l.
Via Isonzo, 71 - 04100 Latina
08.0 MARKETING AUTHORIZATION NUMBER
Bassado 100 mg tablets - 10 tablets A.I.C. n. 021635065
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
29 November 1969/31 May 2010
