Topogel may be available in the countries listed below.
Ingredient matches for Topogel
Ketoprofen
Ketoprofen is reported as an ingredient of Topogel in the following countries:
- Bulgaria
- Georgia
International Drug Name Search
Tuesday, October 25, 2016
Amoxil Syrup Sucrose-Free / Dye-Free 250mg / 5ml
1. Name Of The Medicinal Product
Amoxil® Syrup Sucrose-Free/Dye-Free 250 mg/5 ml
2. Qualitative And Quantitative Composition
Amoxil Syrup SF/DF 250 mg contains 250 mg amoxicillin per 5 ml dose.
The amoxicillin is present as the trihydrate.
3. Pharmaceutical Form
Amoxil Syrup SF/DF 250 mg/5 ml: citrus-flavoured sucrose-free/Dye Freesuspension in a sorbitol base. Presented as powder in bottles for preparing 100 ml.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:
Upper respiratory tract infections
Otitis media
Acute and chronic bronchitis
Chronic bronchial sepsis
Lobar and bronchopneumonia
Cystitis, urethritis, pyelonephritis
Bacteriuria in pregnancy
Gynaecological infections including puerperal sepsis and septic abortion
Gonorrhoea
Peritonitis
Intra-abdominal sepsis
Septicaemia
Bacterial endocarditis
Typhoid and paratyphoid fever
Skin and soft tissue infections
Osteomyelitis
Dental abscess (as an adjunct to surgical management)
In children with urinary tract infection the need for investigation should be considered.
Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.
The wide range of organisms sensitive to the bactericidal action of Amoxil include:
Gram-positive Gram-negative
Streptococcus faecalis Haemophilus influenzae
Streptococcus pneumoniae Escherichia coli
Streptococcus pyogenes Proteus mirabilis
Streptococcus viridans Salmonella species
Staphylococcus aureus Shigella species
(penicillin-sensitive) Bordetella pertussis
Clostridium species Brucella species
Corynebacterium species Neisseria gonorrhoeae
Bacillus anthracis Neisseria meningitidis
Listeria monocytogenesVibrio cholerae
Pasteurella septica
4.2 Posology And Method Of Administration
Treatment of Infection:
Adult dosage (including elderly patients):
Oral:
Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections.
High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.
Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose.
Injectable:
500 mg IM eight hourly (or more frequently if necessary) in moderate infections. (This dose may be given by slow IV injection if more convenient.)
1 g IV six hourly in severe infections.
Children's dosage (up to 10 years of age):
Oral:
Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections.
Amoxil Paediatric Suspension is recommended for children under six months of age.
Prophylaxis of endocarditis:
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In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.
Injectable:
50-100 mg/kg body weight a day, in divided doses.
Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection.
In renal impairment the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage.
Prophylaxis of endocarditis: see table on previous page.
Administration:
Oral
4.3 Contraindications
Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.
4.4 Special Warnings And Precautions For Use
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see 4.3).
Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Section 4.9 Overdose).
Dosage should be adjusted in patients with renal impairment (see 4.2).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
In common with other broad spectrum antibiotics, amoxicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.
4.6 Pregnancy And Lactation
Use in pregnancy:
Animal studies with Amoxil have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.
Use in lactation:
Amoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.
4.7 Effects On Ability To Drive And Use Machines
Adverse effects on the ability to drive or operate machinery have not been observed.
4.8 Undesirable Effects
The following convention has been utilised for the classification of undesirable effects:-
Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)
The majority of side effects listed below are not unique to amoxycillin and may occur when using other pencillins.
Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.
Blood and lymphatic system disorders
Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.
Prolongation of bleeding time and prothrombin (see Section 4.5 - Interaction with other Medicaments and other Forms of Interaction)
Immune system disorders
Very rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).
Nervous system disorders
Very rare: Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders
Clinical Trial Data
*Common: Diarrhoea and nausea.
*Uncommon: Vomiting.
Post-marketing Data
Very rare: Mucocutaneous candidiasis and antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis).
Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.
Hepato-biliary disorders
Very rare: Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.
The significance of a rise in AST and/or ALT is unclear.
Skin and subcutaneous tissue disorders
Clinical Trial Data
*Common: Skin rash
*Uncommon: Urticaria and pruritus
Post-marketing Data
Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)
(See also Immune system disorders).
Renal and urinary tract disorders
Very rare: Interstitial nephritis.
Very rare: Crystalluria (see Section 4.9 Overdose).
*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.
4.9 Overdose
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).
Amoxicillin may be removed from the circulation by haemodialysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Amoxil is a broad spectrum antibiotic.
It is rapidly bactericidal and possesses the safety profile of a penicillin.
5.2 Pharmacokinetic Properties
Amoxil is well absorbed by the oral and parenteral routes. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which food is taken. Amoxil gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Amoxil Syrup SF/DF 250 mg / 5ml
The powder contains disodium edetate, sodium benzoate (E211), saccharin sodium, silica (E551), xanthan gum (E415), peach, strawberry and lemon dry flavours and sorbitol (E420).
6.2 Incompatibilities
None.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Store powder in a dry place. Once dispensed, Amoxil Syrup SF/DF should be used within 14 days. If dilution of the reconstituted SF/DF product is required, water should be used.
6.5 Nature And Contents Of Container
Amoxil Syrup SF/DF 250 mg/5 ml: Original Pack of 100 ml with Patient InformationLeaflet.
6.6 Special Precautions For Disposal And Other Handling
None
Administrative Data
7. Marketing Authorisation Holder
Beecham Group plc
Great West Road, Brentford
Middlesex TW8 9GS
Trading as:
GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
And/or
Bencard or SmithKline Beecham Pharmaceuticals all at Mundells Welwyn Garden City, Hertfordshire AL7 1EY
8. Marketing Authorisation Number(S)
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9. Date Of First Authorisation/Renewal Of The Authorisation
14 May 1985 / 16 January 1998
10. Date Of Revision Of The Text
5th July 2005
11. Legal Status
POM
Celeston valerat
Celeston valerat may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Celeston valerat
Betamethasone
Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Celeston valerat in the following countries:
- Denmark
- Sweden
International Drug Name Search
Ibufen-L
Ibufen-L may be available in the countries listed below.
Ingredient matches for Ibufen-L
Ibuprofen
Ibuprofen lysine (a derivative of Ibuprofen) is reported as an ingredient of Ibufen-L in the following countries:
- Switzerland
Lidocaine
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Ibufen-L in the following countries:
- Switzerland
International Drug Name Search
Non-ionic iodinated contrast media
A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.
See also
Medical conditions associated with non-ionic iodinated contrast media:
- Angiocardiography
- Aortography
- Arthrography
- Body Imaging
- Cerebral Arteriography
- Computed Tomography
- Coronary Arteriography
- Cystourethrography
- Digital Subtraction Angiography
- Endoscopy or Radiology Premedication
- Gastrointestinal Tract Examination
- Head Imaging
- Hysterosalpingography
- Intra-arterial Digital Subtraction Angiography
- Intravenous Digital Subtraction Angiography
- Intravenous Urography
- Left Ventriculography
- Myelography
- Pediatric Angiocardiography
- Peripheral Angiography
- Peripheral Arteriography
- Renal Arteriography
- Urography
- Venography
- Visceral Arteriography
Drug List:
Aciclovir Tablets BP
ACICLOVIR TABLETS
Please read this leaflet carefully before you start to take this medicine. It gives an outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout your course of treatment.
THE NAME OF YOUR MEDICINE IS ACICLOVIR TABLETS
Aciclovir Tablets contain the active ingredient aciclovir. The tablets come in three strengths, 200mg, 400mg and 800mg.
Other ingredients in your tablets are gelatin, lactose, maize starch, microcrystalline cellulose, sodium starch glycollate and magnesium stearate.
Aciclovir 200mg Tablets are white, circular tablets marked ACV 200 on one face, CP on the reverse.
Aciclovir 400mg Tablets are white, oval tablets marked with ACV 400 and a breakline on one face, CP on the reverse.
Aciclovir 800mg Tablets are white, oval tablets marked with ACV 800 and a breakline on one face, CP on the reverse.
Aciclovir 200mg Tablets are available in blister packs of 25 tablets.
Aciclovir 400mg Tablets are available in blister packs of 56 tablets.
Aciclovir 800mg Tablets are available in blister packs of 35 tablets.
Marketing Authorisation Holder:
Wockhardt UK Limited
Ash Road North
Wrexham
LL13 9UF
UK
Manufacturer:
CP Pharmaceuticals Limited
Ash Road North
Wrexham
LL13 9UF
UK
How Does Your Medicine Work?
Aciclovir belongs to a group of medicines called antivirals. These medicines work by stopping viruses from
spreading in the body.
What Are Aciclovir Tablets For?
Aciclovir Tablets are used to treat shingles in adults and infections of the lips or nose (“cold sores”), skin and genitals caused by herpes virus. Aciclovir tablets are also used to prevent repeated herpes infections and to protect people who have a low resistance to disease and have been in contact with herpes.
Doctors sometimes prescribe this medicine for other purposes. If you think this applies to you, ask your doctor.
Before Taking This Medicine
You should not take Aciclovir Tablets if you have ever had a reaction or been told that you are allergic to aciclovir or any of the other ingredients in the tablets. Check by reading the list of ingredients above.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Before taking this medicine, you should let your doctor know if you are pregnant or breast-feeding or planning to become pregnant or start breast-feeding.
Taking another medicine while you are taking Aciclovir Tablets can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are taking Aciclovir Tablets unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself.
Examples of medicines that can affect Aciclovir Tablets are:
- Probenecid, a drug used to prevent gout.
- Zidovudine, another antiviral drug.
- Theophylline, used in asthma.
If you have any doubts about whether you should take this medicine then talk to your doctor.
Advice When Taking Aciclovir Tablets
- It is important to drink plenty of water while you are taking aciclovir.
- Care is required if you have kidney problems, any nervous disorder, liver disease, abnormal levels of electrolytes (salts) in the blood or severe breathing difficulties. Your dosage may be reduced.
- You should not drive or operate machinery until you are sure that the tablets are not affecting your ability to do so.
Taking This Medicine
The usual adult dose of Aciclovir Tablets for the treatment of cold sores, skin or genital herpes is 200mg five times daily (usually every four hours while awake) for five days. For children over two years the dose is the same as the adult dose. For children under two years, the usual dose is 100mg five times a day.
The usual adult dose of Aciclovir Tablets for the prevention of repeated herpes infections is 200mg four times daily or 400mg twice daily, which can be reduced to 200mg two or three times daily. For children over two years the dose is the same as the adult dose. For children under two years, the usual dose is 200mg twice daily. Treatment should be interrupted every 6 -12 months to see if you are free from infection.
The usual adult dose for protection from herpes infections in those with low resistance to disease is 200mg four times daily, which may be increased to 400mg four times daily for severe cases. For children over two years the dose is the same as the adult dose. For children under two years, the usual dose is 100mg four times daily. Treatment should be given for as long as there is a risk of herpes infection.
The usual adult dose for the treatment of shingles in adults is 800mg five times daily (usually every four hours while awake). This should start no later than three days after the first sign of infection and continue for seven days.
Your doctor will decide the dose that is best for you. Always follow your doctor’s instructions completely. Also, follow any instructions or warnings that appear on the label that the pharmacist has put on the pack. If you do not understand, or are in any doubt, ask your doctor or pharmacist.
To remove a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.
Unless told otherwise, swallow your tablets whole with plenty of water.
You should take your medicine for as long as your doctor tells you to. If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Never double the next dose to make up for the one missed. Do not stop taking the medicine without talking to your doctor first.
If you accidentally take too many tablets, you should contact your doctor, pharmacist or nearest hospital casualty department. Take this leaflet and any tablets you have left to show the doctor or pharmacist.
Are There Any Side-Effects?
Like many medicines, Aciclovir Tablets may cause side-effects in some patients, particularly when you first start taking them. The side-effects that some other patients have had with Aciclovir Tablets include kidney problems, blood problems (which could cause sore throats, mouth ulcers, or generally feeling tired or unwell), rashes, sore muscles, swelling of the feet or hands, visual disturbances, itching, fever, headaches, stomach pain, feeling sick, being sick and diarrhoea. There may be some increases in levels of chemicals in the blood, indicating kidney or liver disturbances.
Rarely, swollen glands, allergic reactions (sometimes with fever, rash, swelling of the face and difficulty breathing), liver problems, jaundice (with yellow skin and whites of eyes), thrombocytopenia (reduced blood platelets), hair loss, serious skin conditions such as Steven-Johnsons syndrome, erythema multiforme and toxic epidermal necrolysis, mental illness, psychosis, tiredness, dizziness, drowsiness, confusion, hallucinations, feeling agitated, shaking, “pins and needles”, fits and loss of consciousness have been reported, particularly in older patients or those with renal impairment.
If you experience any other side effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.
Safe Keeping For This Medicine
Do not take this medicine if the expiry date on the label has passed or if the tablets show signs of “going on” such as discoloration.
Do not store these tablets above 25°C. Keep them in the package or container in which they were given to you. Do not transfer Aciclovir Tablets to another container.
Keep Aciclovir Tablets out of the reach and sight of children.
Remember this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.
Unless your doctor tells you to, do not keep medicines that you no longer need. Give them back to your pharmacist.
Other formats:
To listen to or request a copy of the leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name - Reference Number
- Aciclovir 200mg Tablets - 29831/0002
- Aciclovir 400mg Tablets - 29831/0001
- Aciclovir 800mg Tablets - 29831/0003
This is a service provided by the Royal National Institute of the Blind.
DATE OF PREPARATION
August 2007
CP4
103799/1
Monday, October 24, 2016
Medibudget Abführdragées Bisacodyl
Medibudget Abführdragées Bisacodyl may be available in the countries listed below.
Ingredient matches for Medibudget Abführdragées Bisacodyl
Bisacodyl
Bisacodyl is reported as an ingredient of Medibudget Abführdragées Bisacodyl in the following countries:
- Switzerland
International Drug Name Search
Methylin Oral Solution
Generic Name: methylphenidate hydrochloride
Dosage Form: oral solution
Methylin™ Oral Solution
methylphenidate HCl oral solution, 5 mg/5 mL
methylphenidate HCl oral solution, 10 mg/5 mL
CII
Rx only
DESCRIPTION
Methylin™ methylphenidate HCl oral solution, is a mild central nervous system (CNS) stimulant, available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is
Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
Each mL of Methylin™ Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP.
Each mL of Methylin™ Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP.
In addition, Methylin™ Oral Solution also contains the following inactive ingredients: citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water.
CLINICAL PHARMACOLOGY
Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer.
Methylphenidate HCl is a central nervous system (CNS) stimulant.
The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
There is neither specific evidence which clearly establishes the mechanism whereby Methylin produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Pharmacokinetics
Absorption
Methylin Oral Solution is readily absorbed. Following oral administration of Methylin Oral Solution, peak plasma methylphenidate concentrations are achieved at 1 to 2 hours. Methylin Oral Solution has been shown to be bioequivalent to Ritalin® tablet. The mean Cmax following a 20 mg dose is approximately 9 ng/mL.
Food Effect
In a study in adult volunteers to investigate the effects of a high-fat meal on the bioavailability of Methylin Oral Solution at a dose of 20 mg, the presence of food delayed the peak by approximately 1 hour (1.7 hours, fasted and 2.7 hours, fed). Overall, a high-fat meal increased the Cmax of Methylin Oral Solution by about 13% and the AUC by about 25%, on average. Through a cross-study comparison, the magnitude of increase in Cmax and AUC is found to be comparable between the Methylin Oral Solution and Ritalin®, the immediate release tablet.
Metabolism and Excretion
In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenylpiperidine acetic acid (PPA, ritalinic acid). The metabolite has little or no pharmacologic activity.
After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was PPA, accounting for approximately 80% of the dose.
The pharmacokinetics of the Methylin Oral Solution have been studied in healthy adult volunteers. The mean terminal half-life (t ½) of methylphenidate following administration of 20 mg Methylin (t ½ = 2.7 hours) is comparable to the mean terminal t ½ following administration of Ritalin® (methylphenidate hydrochloride immediate-release tablets) (t ½ = 2.8h) in healthy adult volunteers.
Special Populations
Gender – The effect of gender on the pharmacokinetics of methylphenidate after Methylin Oral Solution administration has not been studied.
Race – The influence of race on the pharmacokinetics of methylphenidate after Methylin Oral Solution administration has not been studied.
Age – The pharmacokinetics of methylphenidate after Methylin Oral Solution administration have not been studied in pediatrics.
Renal Insufficiency
There is no experience with the use of Methylin Oral Solution in patients with renal insufficiency. After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of ritalinic acid. Since renal clearance is not an important route of methylphenidate clearance, renal insufficiency is expected to have little effect on the pharmacokinetics of Methylin Oral Solution.
Hepatic Insufficiency
There is no experience with the use of Methylin Oral Solution in patients with hepatic insufficiency.
INDICATIONS AND USAGE
Attention Deficit Disorders, Narcolepsy
Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.
Methylin™ is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
CONTRAINDICATIONS
Marked anxiety, tension, and agitation are contraindications to Methylin, since the drug may aggravate these symptoms. Methylin is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome.
Methylin is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
WARNINGS
Serious Cardiovascular Events
Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems
Children and Adolescents – Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Adults – Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.
Hypertension and other Cardiovascular Conditions
Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.
Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications
Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
Psychiatric Adverse Events
Pre-Existing Psychosis – Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Bipolar Illness – Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
Emergence of New Psychotic or Manic Symptoms – Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.
Aggression – Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.
Long-Term Suppression of Growth
Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Seizures
There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Visual Disturbance
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
USE IN CHILDREN LESS THAN SIX YEARS OF AGE
Methylin should not be used in children under six years, since safety and efficacy in this age group have not been established.
DRUG ABUSE AND DEPENDENCE
Methylin should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Long-term follow-up may be required because of the patient's basic personality disturbances.
PRECAUTIONS
General
Patients with an element of agitation may react adversely; discontinue therapy if necessary.
Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe Methylin should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.
When these symptoms are associated with acute stress reactions, treatment with Methylin is usually not indicated.
Long-term effects of Methylin in children have not been well established.
Information for Patients
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Methylin Oral Solution. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Drug Interactions
Methylin may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.
Human pharmacologic studies have shown that Methylin may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with Methylin.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 2.5 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.
Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 4 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively.
Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. The genotoxic potential of methylphenidate has not been evaluated in an in vivo assay.
Usage in Pregnancy
Adequate animal reproduction studies to establish safe use of Methylin during pregnancy have not been conducted. However, in a recently conducted study, methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 167 times and 78 times the maximum recommended human dose on a mg/kg and a mg/m2 basis, respectively. In rats, teratogenic effects were not seen when the drug was given in doses of 75 mg/kg/day, which is approximately 62.5 and 13.5 times the maximum recommended human dose on a mg/kg and a mg/m2 basis, respectively. Therefore, until more information is available, methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks.
Adverse Reactions
Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette's syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abdominal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.
In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.
OVERDOSAGE
Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.
Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and advice.
Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage. In the presence of severe intoxication, use a carefully titrated dosage of a short-acting barbiturate before performing gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal hemodialysis for methylphenidate overdosage has not been established.
DOSAGE AND ADMINISTRATION
Dosage should be individualized according to the needs and responses of the patient.
Adults
Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Children (6 years and over)
Methylin should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylin should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
HOW SUPPLIED
Methylin™ Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.
- Bottles of 500 mL . . . . . . . . NDC 59630-750-50
Methylin™ Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.
- Bottles of 500 mL . . . . . . . . NDC 59630-755-50
Dispense in tight container with child-resistant closure.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Methylin is a trademark of Mallinckrodt Inc.
Ritalin is a registered trademark of Novartis Corporation.
Manufactured for:
Shionogi Pharma, Inc.
Atlanta, GA 30328
Manufactured by:
Mallinckrodt Inc.
Hazelwood, MO 63042 USA
Rev 10/2010
MEDICATION GUIDE
Methylin™ Oral Solution
(methylphenidate HCl oral solution) 5 mg/5 mL and 10 mg/5 mL
CII
Read the Medication Guide that comes with Methylin Oral Solution before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with Methylin Oral Solution.
What Is Methylin Oral Solution?
Methylin Oral Solution is a central nervous system stimulant prescription medicine. Methylin Oral Solution is a liquid form of medication that you take by mouth. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Methylin Oral Solution may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Methylin Oral Solution should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Methylin Oral Solution is also used in the treatment of a sleep disorder called narcolepsy.
Methylin Oral Solution is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylin Oral Solution in a safe place to prevent misuse and abuse. Selling or giving away Methylin Oral Solution may harm others, and is against the law.
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Who should not take Methylin Oral Solution?
Methylin Oral Solution should not be taken if you or your child:
- are very anxious, tense, or agitated
- have an eye problem called glaucoma
- have tics or Tourette's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
- are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
- are allergic to anything in Methylin Oral Solution. See the end of this Medication Guide for a complete list of ingredients.
Methylin Oral Solution should not be used in children less than 6 years old because it has not been studied in this age group.
Methylin Oral Solution may not be right for you or your child. Before starting Methylin Oral Solution tell your or your child's doctor about all health conditions (or a family history of) including:
- heart problems, heart defects, high blood pressure
- mental problems including psychosis, mania, bipolar illness, or depression
- tics or Tourette's syndrome
- seizures or have had an abnormal brain wave test (EEG)
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can Methylin Oral Solution be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Methylin Oral Solution and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Methylin Oral Solution.
Your doctor will decide whether Methylin Oral Solution can be taken with other medicines.
Especially tell your doctor if you or your child takes:
- antidepression medicines including MAOIs
- seizure medicines
- blood thinner medicines
- blood pressure medicines
- cold or allergy medicines that contain decongestants
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Methylin Oral Solution without talking to your doctor first.
How should Methylin Oral Solution be taken?
- Take Methylin Oral Solution exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
- Methylin Oral Solution is usually taken 2 to 3 times a day.
- Take Methylin Oral Solution 30 to 45 minutes before meals.
- From time to time, your doctor may stop Methylin Oral Solution treatment for awhile to check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart, and blood pressure while taking Methylin Oral Solution. Children should have their height and weight checked often while taking Methylin Oral Solution. Methylin Oral Solution treatment may be stopped if a problem is found during these check-ups.
- If you or your child takes too much Methylin Oral Solution or overdoses, call your doctor or poison control center right away, or get emergency treatment.
What are possible side effects of Methylin Oral Solution?
See “What is the most important information I should know about Methylin Oral Solution?” for information on reported heart and mental problems.
Other serious side effects include:
- slowing of growth (height and weight) in children
- seizures, mainly in patients with a history of seizures
- eyesight changes or blurred vision
Common side effects include:
- nervousness
- trouble sleeping
- headache
- stomach ache
- fast heart beat
- nausea
- decreased appetite
- dizziness
- weight loss
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Methylin Oral Solution?
- Store Methylin Oral Solution in a safe place at room temperature, 68° to 77°F (20° to 25°C).
- Keep Methylin Oral Solution and all medicines out of the reach of children.
General information about Methylin Oral Solution
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylin Oral Solution for a condition for which it was not prescribed. Do not give Methylin Oral Solution to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about Methylin Oral Solution. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Methylin Oral Solution that was written for healthcare professionals. For more information, please contact Shionogi Pharma, Inc. at 1-800-849-9707 or visit the website at www.methylinrx.com.
What are the ingredients in Methylin Oral Solution?
Active Ingredient: methylphenidate hydrochloride USP
Inactive Ingredients: citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Shionogi Pharma, Inc.
Atlanta, GA 30328
Manufactured by:
Mallinckrodt Inc.
Hazelwood, MO 63042 USA
Rev 10/2010
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 mg per 5 mL Bottle
NDC 59630-750-50
500 mL
CII
Methylin™ Oral Solution
methylphenidate HCl oral solution
5 mg per 5 mL
Rx only
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED WITH PRODUCT
SHIONOGI PHARMA, INC.
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 10 mg per 5 mL Bottle
NDC 59630-755-50
500 mL
CII
Methylin™ Oral Solution
methylphenidate HCl oral solution
10 mg per 5 mL
Rx only
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED WITH PRODUCT
SHIONOGI PHARMA, INC.
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021419 | 11/01/2010 | |
| METHYLIN methylphenidate hydrochloride solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021419 | 11/01/2010 | |
| Labeler - Shionogi Pharma, Inc. (802728477) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mallinckrodt Inc. | 957414238 | manufacture, analysis | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mallinckrodt Inc-Pharmaceuticals Group | 163205300 | api manufacture | |
More Methylin Oral Solution resources
- Methylin Oral Solution Side Effects (in more detail)
- Methylin Oral Solution Dosage
- Methylin Oral Solution Use in Pregnancy & Breastfeeding
- Drug Images
- Methylin Oral Solution Drug Interactions
- Methylin Oral Solution Support Group
- 242 Reviews for Methylin - Add your own review/rating
Compare Methylin Oral Solution with other medications
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Equisedan
Equisedan may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Equisedan
Detomidine
Detomidine hydrochloride (a derivative of Detomidine) is reported as an ingredient of Equisedan in the following countries:
- Switzerland
International Drug Name Search
Friday, October 21, 2016
Digex NF
Pronunciation: HYE-oh-SYE-a-meen/FEN-il-tole-OX-a-meen
Generic Name: Hyoscyamine/Phenyltoloxamine
Brand Name: Digex NF
Digex NF is used for:
Relieving symptoms of indigestion (eg, feeling of fullness, gas, bloating). It is also used to treat certain stomach and intestinal conditions, including spasms and cramps. It may also be used for other conditions as determined by your doctor.
Digex NF is an anticholinergic and antihistamine combination. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.
Do NOT use Digex NF if:
- you are allergic to any ingredient in Digex NF
- you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
- you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding
- you are taking sodium oxybate (GHB)
- you are taking potassium chloride capsules or tablets
Contact your doctor or health care provider right away if any of these apply to you.
Before using Digex NF:
Some medical conditions may interact with Digex NF. 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 lung or breathing problems (eg, asthma), nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
- if you have diarrhea or fever, have trouble urinating, have been very ill, or are in poor health
Some MEDICINES MAY INTERACT with Digex NF. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Potassium tablets or capsules because they may not be able to move through the stomach and bowel as well when taken with Digex NF; this may increase the risk of their side effects
- Narcotic pain medicines (eg, codeine) because the risk of their side effects may be increased by Digex NF
- Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Digex NF's side effects
- Ketoconazole or metoclopramide because their effectiveness may be decreased by Digex NF
This may not be a complete list of all interactions that may occur. Ask your health care provider if Digex NF 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.
How to use Digex NF:
Use Digex NF as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Digex NF by mouth with food as directed by your doctor.
- If you also take antacids, take Digex NF before meals and the antacid after meals, unless directed otherwise by your doctor.
- If you open the capsule, do not breathe in the powder. Some patients may experience an allergic reaction (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) from breathing in the powder.
- If you miss a dose of Digex NF, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Digex NF.
Important safety information:
- Digex NF may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Digex NF with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Digex NF; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
- Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
- Proper dental care is important while you are taking Digex NF. Brush and floss your teeth and visit the dentist regularly.
- Digex NF may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
- Tell your doctor or dentist that you take Digex NF before you receive any medical or dental care, emergency care, or surgery.
- Use Digex NF with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
- Caution is advised when using Digex NF in CHILDREN; they may be more sensitive to its effects, including excitability.
- PREGNANCY and BREAST-FEEDING: It is not known if Digex NF can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Digex NF while you are pregnant. Digex NF is found in breast milk. If you are or will be breast-feeding while taking Digex NF, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Digex NF:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; fever; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Digex NF side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.
Proper storage of Digex NF:
Store Digex NF 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 Digex NF out of the reach of children and away from pets.
General information:
- If you have any questions about Digex NF, please talk with your doctor, pharmacist, or other health care provider.
- Digex NF is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Digex NF. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Digex NF resources
- Digex NF Side Effects (in more detail)
- Digex NF Use in Pregnancy & Breastfeeding
- Digex NF Drug Interactions
- Digex NF Support Group
- 0 Reviews · Be the first to review/rate this drug
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