Vermex

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Vermex uses

Vermex consists of Buckwheat, Calcium (Oyster Shells), Capsicum, Cascara Sagrada, Cina, Cinchona Officinalis, Graphite, Mugwort, Sabadilla, Silicon Dioxide, Spigelia Anthelmia, Tanacetum Vulgare.

Calcium (Oyster Shells):


1 INDICATIONS AND USAGE

Vermex (Calcium (Oyster Shells)) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)

2 DOSAGE AND ADMINISTRATION

The recommended initial dose of Vermex (Calcium (Oyster Shells)) acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.

- Starting dose is 2 capsules with each meal. (2)

- Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal. (2)

3 DOSAGE FORMS AND STRENGTHS

Capsule: 667 mg Vermex (Calcium (Oyster Shells)) acetate capsule.

- Capsule: 667 mg Vermex (Calcium (Oyster Shells)) acetate capsule. (3)

4 CONTRAINDICATIONS

Patients with hypercalcemia.

- Hypercalcemia. (4)

5 WARNINGS AND PRECAUTIONS

- Treat mild hypercalcemia by reducing or interrupting Vermex ) acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Vermex (Calcium (Oyster Shells)) acetate. (5.1)

- Hypercalcemia may aggravate digitalis toxicity. (5.2)

5.1 Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with Vermex (Calcium (Oyster Shells)), including Vermex (Calcium (Oyster Shells)) acetate. Avoid the use of Vermex (Calcium (Oyster Shells)) supplements, including Vermex (Calcium (Oyster Shells)) based nonprescription antacids, concurrently with Vermex (Calcium (Oyster Shells)) acetate.

An overdose of Vermex (Calcium (Oyster Shells)) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Vermex (Calcium (Oyster Shells)) levels twice weekly. Should hypercalcemia develop, reduce the Vermex (Calcium (Oyster Shells)) acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia

More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Vermex (Calcium (Oyster Shells)) acetate therapy.

Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the Vermex (Calcium (Oyster Shells)) acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.

Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of Vermex (Calcium (Oyster Shells)) acetate on the progression of vascular or soft tissue calcification has not been determined.

Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of Vermex (Calcium (Oyster Shells)) acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.

5.2 Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

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6 ADVERSE REACTIONS

Hypercalcemia is discussed elsewhere [see Warnings and Precautions ].

- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. (6.1)

- In clinical studies, patients have occasionally experienced nausea during Vermex (Calcium (Oyster Shells)) acetate therapy. (6)

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical studies, Vermex (Calcium (Oyster Shells)) acetate has been generally well tolerated.

Vermex (Calcium (Oyster Shells)) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Vermex (Calcium (Oyster Shells)) acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.


Preferred Term


Total adverse reactions reported for Vermex (Calcium (Oyster Shells)) acetate

N=167

N (%)


3 month, open label study of Vermex (Calcium (Oyster Shells)) acetate

N=98

N (%)


Double blind, placebo-controlled, cross-over study of liquid Vermex (Calcium (Oyster Shells)) acetate

N=69


Vermex (Calcium (Oyster Shells)) acetate

N (%)


Placebo

N (%)


Nausea


6 (3.6)


6 (6.1)


0 (0)


0 (0)


Vomiting


4 (2.4)


4 (4.1)


0 (0)


0 (0)


Hypercalcemia


21 (12.6)


16 (16.3)


5 (7.2)


0 (0)


Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate Vermex (Calcium (Oyster Shells)) concentration could reduce the incidence and severity of Vermex (Calcium (Oyster Shells)) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.

6.2 Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval of Vermex (Calcium (Oyster Shells)) acetate: dizziness, edema, and weakness.

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7 DRUG INTERACTIONS

The drug interaction of Vermex ) acetate is characterized by the potential of Vermex (Calcium (Oyster Shells)) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Vermex (Calcium (Oyster Shells)) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between Vermex (Calcium (Oyster Shells)) acetate and most concomitant drugs. When administering an oral medication with Vermex (Calcium (Oyster Shells)) acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Vermex (Calcium (Oyster Shells)) acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of Vermex (Calcium (Oyster Shells)) acetate.

- Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones. (7)

- When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after Vermex (Calcium (Oyster Shells)) acetate or consider monitoring blood levels of the drug. (7)

7.1 Ciprofloxacin

In a study of 15 healthy subjects, a co-administered single dose of 4 Vermex (Calcium (Oyster Shells)) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C:

Vermex ) acetate capsules contains Vermex (Calcium (Oyster Shells)) acetate. Animal reproduction studies have not been conducted with Vermex (Calcium (Oyster Shells)) acetate, and there are no adequate and well controlled studies of Vermex (Calcium (Oyster Shells)) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Vermex (Calcium (Oyster Shells)) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Vermex (Calcium (Oyster Shells)) levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Vermex (Calcium (Oyster Shells)) acetate treatment, as recommended, is not expected to harm a fetus if maternal Vermex (Calcium (Oyster Shells)) levels are properly monitored during and following treatment.

8.2 Labor and Delivery

The effects of Vermex (Calcium (Oyster Shells)) acetate on labor and delivery are unknown.

8.3 Nursing Mothers

Vermex ) Acetate Capsules contains Vermex (Calcium (Oyster Shells)) acetate and is excreted in human milk. Human milk feeding by a mother receiving Vermex (Calcium (Oyster Shells)) acetate is not expected to harm an infant, provided maternal serum Vermex (Calcium (Oyster Shells)) levels are appropriately monitored.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Vermex (Calcium (Oyster Shells)) acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between 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 of concomitant disease or other drug therapy.

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10 OVERDOSAGE

Administration of Vermex (Calcium (Oyster Shells)) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

11 DESCRIPTION

Vermex (Calcium (Oyster Shells)) acetate acts as a phosphate binder. Its chemical name is Vermex (Calcium (Oyster Shells)) acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:


Each white opaque/blue opaque capsule contains 667 mg of Vermex (Calcium (Oyster Shells)) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Vermex (Calcium (Oyster Shells)), polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.

Vermex (Calcium (Oyster Shells)) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

Chemical Structure

12 CLINICAL PHARMACOLOGY

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Vermex ) resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.

12.1 Mechanism of Action

Vermex (Calcium (Oyster Shells)) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Vermex (Calcium (Oyster Shells)) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

12.2 Pharmacodynamics

Orally administered Vermex (Calcium (Oyster Shells)) acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with Vermex (Calcium (Oyster Shells)) acetate.

14 CLINICAL STUDIES

Effectiveness of Vermex (Calcium (Oyster Shells)) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Vermex (Calcium (Oyster Shells)) acetate solid oral dosage form.

Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.

The patients received Vermex (Calcium (Oyster Shells)) acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.

The data presented in Table 2 demonstrate the efficacy of Vermex (Calcium (Oyster Shells)) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Vermex (Calcium (Oyster Shells)) levels are also presented.


* Ninety-one patients completed at least 6 weeks of the study.

ANOVA of difference in values at pre-study and study completion.

‡ Values expressed as mean ± SE.


Parameter


Pre-Study


Week 4*


Week 8


Week 12


p-value†


Phosphorus (mg/dL)‡


7.4 ± 0.17


5.9 ± 0.16


5.6 ± 0.17


5.2 ± 0.17


≤0.01


Vermex (Calcium (Oyster Shells)) (mg/dL)‡


8.9 ± 0.09


9.5 ± 0.10


9.7 ± 0.10


9.7 ± 0.10


≤0.01


There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum Vermex (Calcium (Oyster Shells)) increased 9% during the study mostly in the first month of the study.

Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive Vermex (Calcium (Oyster Shells)) acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.

The phosphate binding effect of Vermex (Calcium (Oyster Shells)) acetate is shown in the Table 3.


* ANOVA of Vermex (Calcium (Oyster Shells)) acetate vs. placebo after 2 weeks of treatment.

Values expressed as mean ± SEM.


Parameter


Pre-Study


Post-Treatment


p-value*


Vermex (Calcium (Oyster Shells)) Acetate


Placebo


Phosphorus (mg/dL)


7.3 ± 0.18


5.9 ± 0.24


7.8 ± 0.22


<0.01


Vermex (Calcium (Oyster Shells)) (mg/dL)


8.9 ± 0.11


9.5 ± 0.13


8.8 ± 0.12


<0.01


Overall, 2 weeks of treatment with Vermex (Calcium (Oyster Shells)) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Vermex (Calcium (Oyster Shells)) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

16 HOW SUPPLIED/STORAGE AND HANDLING

Vermex (Calcium (Oyster Shells)) Acetate Capsules

667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body.

NDC 0615-2303-39: Blistercards of 30 Capsules

NDC 0615-2303-30: Unit-dose Boxes of 30 Capsules

STORAGE

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Inform patients to take Vermex (Calcium (Oyster Shells)) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Vermex (Calcium (Oyster Shells)) supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].

Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Vermex (Calcium (Oyster Shells)) acetate capsules.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003705/05

Revised April 2016

Capsicum:



Active Ingredients Purpose

Vermex (Capsicum).025% Topical Analgesic

Uses

Uses Temporarily relieves minor pain of muscles and joints associated with:

  • arthritis
  • simple back ache

  • strains
  • bruises

Warnings

Warnings For external use only.

When using this product

When using this product

  • use only as directed
  • do not bandage
  • do not use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if

Stop use and ask a doctor

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If pregnant or breastfeeding

If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

adults and children over 18 years:

  • apply to affected area
  • massage into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING
  • children 18 years or younger: ask a doctor


Keep out of the reach of children.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

Adults and children 2 years of age and older:

  • Apply to painful muscles and joint. Gently massage thoroughly into affected area.
  • Repeat as necessary but not more than 4 times daily.

Purpose

Active Ingredients Purpose

Vermex (Capsicum).025%... Topical Analgesic

Inactive Ingredients

Aqueous (Deionized Water) infusion of botanicalextracts of Passiflora Incarnata, Arnica Montana, Ruscus Acluteatus, HypericumPerforatum, Arctium Lappa, Anthemis Nobilis, *Aloe Barbadensis, Custom blend of*Helianthus annuus (Sunflower Oil),* Olea Europaea (Olive Oil), *SimmondsiaChinenesis (Jojoba Oil), *Linum Usitatissimum (Flax Seed Oil), BoswelliaSerrata, Methylsulfonylmethane, Glycerin,Ceteareth-20, Cetyl Alcohol, Stearyl Alcohol, Juniperus Communis Oil, OriganumMarjorana Oil, Lavandula Officinalis Oil, Rosmarinus Officianalis Oil, ThymusZygis Oil, Tocopherol (Vitamin E), Phenoxyethanol, Ethylhexylglycerin

Cina:


Pharmacological action

Vermex is a broad-spectrum antimicrobial drug of fluoroquinolone group with bactericidal action. Inhibits DNA gyrase and inhibits the synthesis of bacterial DNA. Highly active against most gram-negative bacteria: Pseudomonas aeruginosa, Haemophilus influenzae, Escherichia coli, Shigella spp., Salmonella spp., Neisseria meningitidis, Neisseria gonorrhoeae.

Vermex (Cina) is active against Staphylococcus spp. (including strains producing and not producing penicillinase, methicillin-resistant strains), some strains of Enterococcus spp., Campylobacter spp., Legionella spp., Mycoplasma spp., Chlamydia spp., Mycobacterium spp.

ciprofloxacin is active against bacteria producing beta-lactamases.

Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides resistant to ciprofloxacin. The effect on Treponema pallidum is studied not enough.

Pharmacokinetics

Vermex (Cina) rapidly absorbed from the gastrointestinal tract. Bioavailability after oral administration of 70%. Eating has a little effect on the absorption of ciprofloxacin. Plasma protein binding is 20-40%. Distributed in tissues and body fluids. It penetrates the cerebrospinal fluid: the concentration of ciprofloxacin for not inflamed meninges reach 10% with inflammation - up to 37%. High concentrations are achieved in bile. Excreted in the urine and bile.

Why is Vermex prescribed?

Infectious-inflammatory diseases caused by microorganisms susceptible to ciprofloxacin, including respiratory diseases, diseases of abdominal and pelvic organs, bones, joints, skin, septicemia; severe infections of ENT organs. Treatment of postoperative infections. Prevention and treatment of infections in patients with reduced immunity.

For Vermex (Cina) local use: acute and subacute conjunctivitis, blepharoconjunctivitis, blepharitis, bacterial corneal ulcers, keratitis, keratoconjunctivitis, chronic dacryocystitis, meybomity. Infectious lesions in the eyes from injury or contact with foreign bodies. Preoperative prophylaxis in ophthalmic surgery.

Dosage and administration

Individual. For oral administration dose of Vermex is 250-750 mg 2 times / day. Treatment duration is from 7-10 days to 4 weeks.

For IV administration a single dose is 200-400 mg, the multiplicity of the introduction is 2 times / day, duration of treatment - 1-2 weeks and more if necessary. May be IV injected as jet but more preferably a drip for 30 minutes.

When Vermex (Cina) applied topically instilled 1-2 drops into the lower conjunctival sac of the affected eye every 1-4 hours. After improving the intervals between instillation can be increased. The maximum oral daily dose for adults is 1.5 g.

Vermex (Cina) side effects, adverse reactions

Digestive system: nausea, vomiting, diarrhea, abdominal pain, increase in liver transaminases, alkaline phosphatase, LDH, bilirubin, pseudomembranous colitis.

CNS: headache, dizziness, fatigue, insomnia, nightmares, hallucinations, fainting, disorders of vision.

Urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, hematuria, transient increase of serum creatinine.

Hemopoietic system: eosinophilia, leukopenia, neutropenia, changes in the number of platelets.

Cardiovascular system: tachycardia, cardiac arrhythmias, hypotension.

Allergic reactions: itching, urticaria, Quincke's edema, Stevens-Johnson syndrome, arthralgia.

Adverse reactions associated with the chemotherapeutic effect: candidiasis.

Local reactions: pain, phlebitis (for IV injections). When applying eye drops in some cases may be mild pain and conjunctival hyperemia.

Other: vasculitis.

Contraindications

Pregnancy, lactation, childhood and adolescence to 15 years, increased sensitivity to ciprofloxacin and other drugs hinolonovogo series; deficiency of glucose-6-phosphate dehydrogenase; in ophthalmology: viral keratitis.

Vermex (Cina) Zota Health Care: restrictions to using

Pronounced cerebral arteriosclerosis, cerebral circulatory disorder, mental illness, epilepsy, epileptic syndrome, marked renal and / or hepatic insufficiency.

Using during pregnancy and breastfeeding

Contraindicated in pregnancy ; ciprofloxacin crosses the placenta, excreted in breast milk.

In experimental studies found that it causes arthropathy. In experiments on rats and mice treated with ciprofloxacin in doses exceeding the usual daily dose for a person 6 times, adverse effects on the fetus is not revealed. In experiments on rabbits treated with oral dose of ciprofloxacin 30 and 100 mg / kg, it is shown that the drug causes disruption of the gastrointestinal tract, leading to loss of body weight in females and increase the number of miscarriages but teratogenicity not found. When IV introduction to the doses of 20 mg / kg ciprofloxacin did not exert toxic effects on the mother and embryo, showed no teratogenicity. The use of local forms of ciprofloxacin in pregnancy is possible if the anticipated benefits exceed the potential risk to the fetus.

Category of the fetus by FDA - C.

Ciprofloxacin is excreted in breast milk, so the period of lactation should decide, stop taking ciprofloxacin or breastfeeding based on the degree of importance of the use of drugs for the mother.

With careful use of local forms of ciprofloxacin in breast-feeding (not known whether ciprofloxacin is excreted in breast milk when applied topically).

Special instructions

Patients with impaired renal function requires correction dosing regimen. With caution used in elderly patients, with cerebral arteriosclerosis, cerebral circulatory disorders, epilepsy, convulsive syndrome of unknown etiology.

During treatment patients with Vermex (Cina) should receive enough amounts of liquids.

In the case of persistent diarrhea ciprofloxacin should not be taken.

At the same time of ciprofloxacin IV introduction and barbiturates is necessary to monitor heart rate, blood pressure, ECG. In the course of treatment is necessary to monitor blood concentrations of urea, creatinine, hepatic transaminases.

In the period of treatment may decrease the reactivity (especially when used with alcohol).

Not allowed the introduction of ciprofloxacin subconjunctival or directly into the anterior chamber of the eye.

Precautionary measures

Due to the threat of adverse reactions from the CNS ciprofloxacin should be used only according to the life in the pathology of the CNS in history: organic brain lesions, epilepsy, lowering the convulsive threshold, severe atherosclerosis of the brain, the elderly, with severely impaired renal function and liver (requires monitoring concentrations in blood plasma).

Patients with allergic reactions to fluoroquinolone derivatives in history may develop reactions to ciprofloxacin. During the period of treatment should avoid sunlight and UV radiation, intense physical exercise, control of drinking mode, pH of urine.

Reported cases of crystalluria, particularly in patients with alkaline reaction of urine (pH 7 or more). In order to avoid the development of crystalluria unacceptable excess of the recommended daily dose, should also be adequate fluid intake and maintaining acidic urine.

If you have pain in the tendons or the first signs tendovaginitah treatment should be discontinued (described isolated cases of inflammation or tendon rupture during fluoroquinolone treatment).

It can reduce the speed of psychomotor reactions, especially against the backdrop of alcohol, that should be considered for patients who work with potentially dangerous machinery or drive vehicles.

If you have severe diarrhea, pseudomembranous colitis should be excluded (for which Vermex (Cina) is contraindicated). At the same time of barbiturates IV injections requires monitoring function of the cardiovascular system (heart rate, BP, ECG). Teenagers under 18 years shall be appointed only if the pathogen resistance to other chemotherapeutic drugs. The solution in the form of eye drops are not designed for intraocular injections. The use of other ophthalmic means the interval between injections should be at least 5 minutes.

Vermex (Cina) drug interactions

Activity increases when combined with beta-lactam antibiotics, aminoglycosides, vancomycin, clindamycin, metronidazole. Sukralfat, bismuth preparations, antacids containing aluminum ions, magnesium or calcium, cimetidine, ranitidine, vitamin and mineral supplement, iron sulfate, zinc, didanosine (recommended for 2 hours before or 4 hours after these drugs) reduce the suction. Probenecid, azlocillin increase the concentration in the blood. Decreases clearance and increases in plasma caffeine, aminophylline and theophylline (increased likelihood of side effects). Vermex (Cina) enhances the effect of warfarin and other oral anticoagulants (prolongs bleeding time). Increases nephrotoxicity of cyclosporine, increase the risk of CNS excitability and convulsive reactions against the background of NSAIDs. Medicines alkalinizing the urine (citrates, sodium bicarbonate, carbonic anhydrase inhibitors) reduce the solubility (increases the probability of crystalluria). Infusion solutions of ciprofloxacin ready to use can be combined with infusion solutions: 0.9% sodium chloride solution, Ringer's solution, Ringer lactate, 5 and 10% dextrose, 10% solution of fructose, and a solution containing 5% dextrose with 0,225 or 0.45% sodium chloride. Incompatible with solutions having a pH > 7.

Vermex in case of emergency / overdose

May occur after receiving a single large dose or prolonged use. If a single dose of less than 150 mg / kg, acute poisoning feel light, 150-300 mg / kg - moderate, when using higher doses - heavy.

Symptoms: No specific symptoms.

Treatment: gastric lavage, the use of emetic drugs, the introduction of large quantities of liquid, the creation of acidic urine, in addition - hemodialysis and peritoneal dialysis (can be derived only 10% of the drug), all events are held on the background to maintain vital functions. The specific antidote is unknown.

Vermex pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Vermex available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Vermex destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Vermex Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Vermex pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."THERAPEUTIC HERBAL MUSCLE CALM CAPSICUM (CAPSICUM) LOTION [ECO-LOGICS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CALCIUM: 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/dailym... (accessed August 28, 2018).
  3. "Buckwheat". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Vermex?

Depending on the reaction of the Vermex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Vermex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Vermex addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Vermex, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Vermex consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

One visitor reported doses

What is the dose of Vermex drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 501mg-1g. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
501mg-1g1
100.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

One visitor reported age

Visitors%
> 601
100.0%

Visitor reviews


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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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