Isoglaucon may be available in the countries listed below.
Clonidine hydrochloride (a derivative of Clonidine) is reported as an ingredient of Isoglaucon in the following countries:
International Drug Name Search
Generic Name: Ziprasidone
Class: Atypical Antipsychotics
VA Class: CN709
Chemical Name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one monohydrochloride monohydrate
Molecular Formula: C21H21ClN4OS•HCl•H2OC21H21ClN4OS•CH4O3S•3H2O
CAS Number: 138982-67-9
Special Alerts:
[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .
Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis† receiving atypical antipsychotic agents (e.g., aripiprazole, olanzapine, quetiapine, risperidone) compared with those receiving placebo (2.6%).1 68
Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).1 68
Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.1 68 (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
Atypical or second-generation antipsychotic agent.1 4 10 11 29
Symptomatic management of schizophrenia.1
Should be reserved for patients whose disease fails to respond adequately to appropriate courses of other antipsychotic agents because of a greater capacity to prolong the QT/QTc-interval compared with that of several other antipsychotic agents.1 (See Prolongation of QT Interval under Cautions)
IM injection used for rapid control of behaviors that interfere with diagnosis and care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior).1
Treatment of acute manic and mixed epsiodes (with or without psychotic features) associated with bipolar 1 disorder.1 73 74
Administer orally or by IM injection.1
Concomitant use of oral and IM ziprasidone not recommended by manufacturer.1
Administer orally twice daily with food.1
Vials are for single use only.1
Reconstitute vial containing 20 mg with 1.2 mL of sterile water for injection to provide a solution containing 20 mg/mL.1 Do not use other solutions to reconstitute the injection, and do not admix with other drugs.1 Shake vigorously to ensure complete dissolution.1
Observe strict aseptic technique since the drug contains no preservative.1 Discard unused portions.1
Available as ziprasidone hydrochloride or ziprasidone mesylate; oral dosage expressed in terms of hydrochloride monohydrate and IM dosage expressed in terms of ziprasidone.1 12
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Initially, 20 mg twice daily.1
Dosage may be increased after a minimum of 2 days.1 12 Observe patients for several weeks prior to upward titrations of dosage to ensure use of the lowest effective dosage.1
In patients responding to ziprasidone therapy, continue the drug as long as clinically necessary and tolerated, but at lowest possible effective dosage;12 periodically reassess need for continued therapy.1 Efficacy maintained for up to 52 weeks in clinical trials, but optimum duration of therapy currently is not known.1
Initially, 10–20 mg given as a single dose.1
Repeat doses of 10 mg every 2 hours or 20 mg every 4 hours, up to a maximum cumulative dosage of 40 mg daily.1
Oral therapy should replace IM therapy as soon as possible; safety and efficacy of administering ziprasidone IM injection for longer than 3 consecutive days not evaluated.1
Initially, 40 mg twice daily on day 1.1 Increase dosage to 60 or 80 mg twice daily on the second day.1
Subsequent dosage adjustments based on efficacy and tolerability may be made within a dosage range of 40–80 mg twice daily.1
Efficacy for long-term use (i.e., >3 weeks) or for prophylactic use in patients with bipolar disorder not systematically evaluated.1 If used for extended periods, periodically reevaluate the long-term risks and benefits for the individual patient.1
Maximum 80 mg twice daily.1 12
Maximum cumulative dosage of 40 mg daily.
Maximum 80 mg twice daily.1
Known history of QT interval prolongation (including congenital long QT syndrome), recent AMI, or uncompensated heart failure.1 (See Prolongation of QT Interval under Cautions.)
Concomitant therapy with other drugs that prolong the QT interval (e.g., class Ia and III antiarrhythmics, arsenic trioxide, chlorpromazine, dofetilide, dolasetron mesylate, droperidol, gatifloxacin, halofantrine, levomethadyl acetate, mefloquine, mesoridazine, moxifloxacin, pentamidine, pimozide, probucol, quinidine, sotalol, sparfloxacin, tacrolimus, thioridazine).1 Ziprasidone also is contraindicated in patients receiving drugs shown to cause QT prolongation as an effect and for which this effect is described in the full prescribing information as a contraindication or a boxed or bolded warning.1
Known hypersensitivity to ziprasidone.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Possible increased risk of death with use of atypical antipsychotics in geriatric patients with dementia-related psychosis.1 68 (See Boxed Warning and see Geriatric Use under Cautions.)
Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.1 68
Greater capacity to prolong the QT/QTc interval compared with that of several other antipsychotic agents.1
Experience is too limited to rule out the possibility that ziprasidone may be associated with a greater risk of ventricular arrhythmias (e.g., torsades de pointes) and/or sudden death than other antipsychotic agents.1
Patients at particular risk of torsades de pointes include those with bradycardia, hypokalemia, or hypomagnesemia, those receiving concomitant therapy with other drugs that prolong the QTc interval, and those with congenital prolongation of QTc interval.1 (See Contraindications under Cautions.) Avoid ziprasidone therapy in patients with history of cardiac arrhythmias.1
Determine baseline serum potassium and magnesium concentrations in patients at risk for substantial electrolyte disturbances, particularly those receiving concomitant diuretic therapy.1 Correct hypokalemia or hypomagnesemia prior to initiating ziprasidone.1
Clinical and ECG monitoring of cardiac function, including appropriate ambulatory ECG monitoring (e.g., Holter monitoring), is recommended during ziprasidone therapy in patients with symptoms that could indicate torsades de pointes (e.g., dizziness, palpitations, syncope).1
Discontinue ziprasidone if the QTc interval exceeds 500 msec.1
Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, may occur in patients receiving antipsychotic agents.1 12
Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, has been reported.1 Consider discontinuance of ziprasidone.1
Severe hyperglycemia, sometimes associated with ketoacidosis, hyperosmolar coma, or death, reported in patients receiving atypical antipsychotic agents.1 13 14 15 16 17 18 19 20 21 22 23 24 25 26 40 41 42 43 47 Closely monitor patients with preexisting diabetes mellitus for worsening of glucose control, and perform fasting glucose tests at baseline and periodically for patients with risk factors for diabetes (e.g., obesity, family history of diabetes).1 13 14 16 17 18 19 20 21 22 23 24 25 If manifestations of hyperglycemia occur, test for diabetes mellitus.1 13 14 16 17 18 19 20 21 22 23 24 25
Rash and/or urticaria, possibly related to dose and/or duration of therapy, reported.1 Adjunctive treatment with antihistamines or steroids and/or drug discontinuance may be required.1 Discontinue ziprasidone if alternative etiology of rash cannot be identified.1
Orthostatic hypotension reported, particularly during initial dosage titration period.1 Use with caution in patients with known cardiovascular or cerebrovascular disease and/or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, concomitant antihypertensive therapy).1
Possible risk of seizures;1 use with caution in patients with a history of seizures or with conditions known to lower the seizure threshold (e.g., dementia of the Alzheimer’s type, geriatric patients).1
Disruption of ability to reduce core body temperature possible; use caution in patients exposed to conditions that may contribute to an elevation in core body temperature (e.g., dehydration, extreme heat, strenuous exercise, concomitant use of anticholinergic agents).1
Somnolence reported.1 Potential impairment of judgment, thinking, or motor skills.1
Esophageal dysmotility and aspiration possible; use with caution in patients at risk for aspiration pneumonia (e.g., geriatric patients, those with advanced Alzheimer’s dementia).1 (See Boxed Warning and see Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
Attendant risk with psychotic illnesses; closely supervise high-risk patients.1 Prescribe in the smallest quantity consistent with good patient management to reduce the risk of overdosage.1
Priapism possible.1
Elevated prolactin concentrations possible.7
Weight gain possible.1 7 May cause less weight gain than clozapine, olanzapine, quetiapine, or risperidone.4 10 11 12
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Category C.1
Not known whether ziprasidone is distributed into milk.1 Women receiving ziprasidone should not breast-feed.1
Safety and efficacy not established in children <18 years of age.1
No substantial differences in safety of oral ziprasidone relative to younger adults.1
Lower initial dosages, slower titration, and careful monitoring during the initial dosing period may be advisable in some geriatric patients.1
IM ziprasidone mesylate not systematically evaluated in geriatric patients.1
Possible increased risk of death in geriatric patients with dementia-related psychosis.1 68 Substantial (1.6- to 1.7-fold) increase in mortality rate reported in geriatric patients with dementia who received atypical antipsychotic agents (e.g., aripiprazole, olanzapine, quetiapine, risperidone) for treatment of behavioral disorders; most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).1 68
Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.1 68 (See Boxed Warning and see Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
Commercially available ziprasidone mesylate injections contain sulfobutylether β-cyclodextrin sodium, an excipient that is cleared by renal filtration; use with caution.1
Oral therapy for schizophrenia: somnolence, respiratory tract infection.1
Oral therapy for bipolar mania: somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting.1 73 74
IM therapy for acute agitation in schizophrenia: somnolence, headache, nausea.1
Ziprasidone is metabolized by the CYP3A4 isoenzyme; CYP1A2 also may contribute but to a much lesser extent.1 Little inhibitory effect on CYP isoenzymes 1A2, 2C9, 2C19, 2D6, or 3A4; pharmacokinetic interaction unlikely with drugs metabolized by these isoenzymes.1
Potential pharmacokinetic interactions (altered metabolism) with inhibitors or inducers of CYP3A4.1
Pharmacokinetic interaction with inhibitors or inducers of CYP1A2, CYP2C9, CYP2C19, or CYP2D6 are unlikely.1
Potential pharmacologic interaction (additive effect on QT interval prolongation; concomitant use contraindicated) when used with drugs that prolong the QTc interval.1 Ziprasidone also is contraindicated in patients receiving drugs shown to cause QT prolongation as an effect and for which this effect is described in the full prescribing information as a contraindication or a boxed or bolded warning.1 (See Contraindications and Prolongation of QT Interval under Cautions.)
Drug | Interaction | Comments |
|---|---|---|
Antacids | No effects on ziprasidone pharmacokinetics1 | |
Antiarrhythmics (class Ia and III) | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Arsenic trioxide | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Benztropine | Pharmacokinetic interaction unlikely1 | |
Carbamazepine | Increased ziprasidone metabolism1 | |
Chlorpromazine | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Cimetidine | No change observed in ziprasidone pharmacokinetics1 | |
CNS agents | Additive sedative effects12 | |
Dextromethorphan | No change observed in dextromethorphan metabolism1 | |
Dofetilide | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Dolasetron mesylate | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Dopamine agonists | Antagonistic effects1 | |
Droperidol | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Gatifloxacin | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Halofantrine | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Hypotensive agents | Additive hypotensive effects1 | Use with caution1 |
Ketoconazole | Increased plasma ziprasidone concentrations1 | |
Levodopa | Antagonistic effects1 | |
Levomethadyl acetate | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Lithium | No change observed in lithium clearance1 | |
Lorazepam | Pharmacokinetic interaction unlikely1 | |
Mefloquine | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Mesoridazine | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Moxifloxacin | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Oral contraceptives | No change observed in estradiol or levonorgestrel pharmacokinetics1 | |
Pentamidine | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Pimozide | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Probucol | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Protein-bound drugs (e.g., propranolol, warfarin) | Pharmacokinetic interaction unlikely1 | |
Quinidine | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Sotalol | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Sparfloxacin | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Tacrolimus | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Thioridazine | Increased risk of QT interval prolongation1 | Concomitant use contraindicated1 |
Absolute bioavailability is approximately 60% following a 20 mg oral dose under fed conditions.1
Peak plasma concentrations occur 6–8 hours after oral administration or about 1 hour after IM injection.1
Food increases the absorption up to twofold.1
Not known whether the drug is distributed into milk in humans.1
>99% bound to plasma proteins, principally to albumin and α1-acid glycoprotein.1
Extensively metabolized in the liver principally via reduction by aldehyde oxidase; about one-third of metabolic clearance is mediated by CYP isoenzymes, principally CYP3A4.1
Approximately 20% of a dose is excreted in the urine and about 66% in feces, principally as metabolites.1 Not removed by hemodialysis.1
Mean terminal half-life following oral administration is about 7 hours;1 following IM administration, the half-life is 2–5 hours.1
In patients with clinically important (Child-Pugh class A or B) cirrhosis, half-life increased by 2.3 hours compared with that of patients in the control group.1
15–30°C.1
15–30°C.1
Following reconstitution, store at 15–30°C protected from light for up to 24 hours or at 2–8°C for up to 7 days.1
Exact mechanism of antipsychotic action has not been fully elucidated; may involve antagonism of central type 2 serotonergic (5-HT2) receptors and central dopamine D2 receptors.1 8 9
Precise mechanism of antimanic action has not been fully elucidated.1
Antagonism of other receptors (e.g., histamine H1 receptors, α1-adrenergic receptors) may contribute to other therapeutic and adverse effects (e.g., orthostatic hypotension, somnolence).1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of taking medication exactly as prescribed by the clinician.1
Importance of avoiding driving, operating machinery, or performing hazardous tasks until gain experience with the drug’s effects.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription or OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses (e.g., diabetes mellitus, seizures, dementia).1
Importance of avoiding alcohol during ziprasidone therapy.1
Importance of avoiding overheating or dehydration.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 20 mg | Geodon | Pfizer |
40 mg | Geodon | Pfizer | ||
60 mg | Geodon | Pfizer | ||
80 mg | Geodon | Pfizer |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, for IM use only | 20 mg (of ziprasidone) per mL | Geodon (with sulfobutylether β-cyclodextrin sodium 294 mg/mL) | Pfizer |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Geodon 20MG Capsules (PFIZER U.S.): 60/$478.01 or 180/$1402.96
Geodon 40MG Capsules (PFIZER U.S.): 60/$482.99 or 180/$1407.94
Geodon 60MG Capsules (PFIZER U.S.): 60/$574.97 or 180/$1687.92
Geodon 80MG Capsules (PFIZER U.S.): 60/$574.97 or 180/$1687.92
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. Pfizer Inc. Geodon (ziprasidone) capsules and for injection prescribing information. New York, NY; 2005 May.
2. Daniel DG, Zimbroff DL, Potkin SG et al. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 6-week placebo-controlled trial. Ziprasidone Study Group. Neuropsychopharmacology. 1999; 20:491-505.
3. Keck P, Buffenstein A, Ferguson J et al. Ziprasidone 40 and 120 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 4-week placebo-controlled trial. Psychopharmacology1998; 140:173-84.
4. Taylor D. Ziprasidone: an atypical antipsychotic. Pharmaceutical J. 2001; 266:396-401.
5. Bagnall AM, Lewis RA, Leitner ML. Ziprasidone for schizophrenia and severe mental illness. Cochrane Database Syst Rev. 2000; 4:CD001945. [PubMed 11034737]
6. Goff DC, Posever T, Herz L et al. An exploratory haloperidol-controlled dose-finding study of ziprasidone in hospitalized patients with schizophrenia or schizoaffective disorder. J Clin Psychopharmacol. 1998 Aug; 18:296-304.
7. Pfizer, New York, NY: Personal communication.
8. Lilly. Zyprexa (olanzapine tablets and orally disintegrating tablets) prescribing information. Indianapolis, IN; 2001 Feb.
9. Janssen Pharmaceutica. Risperdal (risperidone tablets and oral solution) prescribing information. Titusville, NJ; 1999 May.
10. Anon. Ziprasidone (Geodon) for schizophrenia. Med Lett Drugs Ther. 2001; 43:51-2. [PubMed 11402259]
11. Carnhan RM, Lund BC, Perry PJ. Ziprasidone, a new atypical antipsychotic drug. Pharmacotherapy. 2001; 21:717-30. [IDIS 465839] [PubMed 11401184]
12. Pfizer, New York, NY: Personal communication.
13. Eli Lilly and company. Zyprexa (olanzapine) tablets and Zyprexa Zydis (olanzapine) orally disintegrating tablets prescribing information. Indianapolis, IN; 2003 Sep 16.
14. Eli Lilly and Company. Lilly announces FDA notification of class labeling for atypical antipsychotics regarding hyperglycemia and diabetes. Indianapolis, IN; 2003 Sep 17. Press release.
15. Cunningham F, Lambert B, Miller DR et al. Antipsychotic induced diabetes in veteran schizophrenic patients. In: Abstracts of the 1st International Conference on Therapeutic Risk Management and 19th International Conference on Parmacoepidemiology, Philadelphia, PA, Aug 21-24. Pharmacoepidemiol Drug Saf. 2003; 12(suppl 1): S154-5.
16. Otsuka America Pharmaceutical, Inc. Abilify (aripiprazole) tablets prescribing information. Rockville, MD; 2004 Sep.
17. Novartis Pharmaceuticals. Clozaril (clozapine) prescribing information. East Hanover, NJ; 2003 Dec.
18. AstraZeneca Pharmaceuticals. Seroquel (quetiapine fumarate) tablets prescribing information. Wilmington, DE; 2004 Jul.
19. Janssen Pharmaceutica. Risperdal (risperidone) tablets and oral solution prescribing information. Titusville, NJ; 2003 Oct.
20. Lewis-Hall F. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. Princeton, NJ: Bristol-Myers Squibb Company; 2004 Mar 25. From FDA website.
21. Bess AL, Cunningham SR. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2004 Apr 1. From the FDA website.
22. Eisenberg P. Dear health care professional letter regarding safety data on Zyprexa (olanzapine) – hyperglycemia and diabetes. Indianapolis, IN: Eli Lilly and Company; 2004 Mar 1. From the FDA website.
23. Macfadden W. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. Wilmington, DE: AstraZeneca Pharmaceuticals; 2004 Apr 22. From the FDA website.
24. Mahmoud RA. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. Titusville, NJ: Janssen Pharmaceutica, Inc; 2004. From the FDA website.
25. Clary CM. Dear health care practitioner letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. New York NY: Pfizer Global Pharmaceuticals; 2004 Aug. From the FDA website.
26. American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity.. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004; 27:596-601. [PubMed 14747245]
27. Melkersson K, Dahl ML. Adverse metabolic effects associated with atypical antipsychotics. Drugs. 2004; 64:701-23. [PubMed 15025545]
28. Citrome LL, Jaffe AB. Relationship of atypical antipsychotics with development of diabetes mellitus. Ann Pharmacother. 2003; 37:1849-57. [IDIS 510453] [PubMed 14632602]
29. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. Am J Psychiatr. 2004; 161(Suppl):1-56.
30. Sumiyoshi T, Roy A, Anil AE et al. A comparison of incidence of diabetes mellitus between atypical antipsychotic drugs. J Clin Psychopharmacol. 2004; 24:345-8. [IDIS 515736] [PubMed 15118492]
31. Expert Group. ’Schizophrenia and Diabetes 2003’ expert consensus meeting, Dublin, 3–4 October 2003: consensus summary. Br J Psychiatry. 2004; 47(Suppl):S112-4.
32. Marder SR, Essock SM, Miller AL et al. Physical health monitoring of patients with schizophrenia. Am J Psychiatry. 2004; 161:1334-49. [IDIS 520856] [PubMed 15285957]
33. Holt RI. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to consensus statement. Diabetes Care. 2004; 27:2086-7. [IDIS 524618] [PubMed 15277449]
34. Citrome L, Volavka J. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to consensus statement. Diabetes Care. 2004; 27:2087-8. [IDIS 524619] [PubMed 15277450]
35. Isaac MT, Isaac MB. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to consensus statement. Diabetes Care. 2004; 27:2088. [IDIS 524620] [PubMed 15277451]
36. Boehm G, Racoosin JA, Laughren TP et al. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to consensus statement. Diabetes Care. 2004; 27:2088-9. [IDIS 524621] [PubMed 15277452]
37. Barrett EJ. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to Holt, Citrome and Volevka, Isaac and Isaac, and Boehm et al. Diabetes Care. 2004; 27:2089-90.
38. Fuller MA, Shermock KM, Secic M et al. Comparative study of the development of diabetes mellitus in patients taking risperidone and olanzapine. Pharmacotherapy. 2002; 23:1037-43.
39. Koller EA, Cross JT, Doraiswamy PM et al. Risperidone-associated diabetes mellitus: a pharmacovigilance study. Pharmacotherapy. 2003; 23:735-44. [IDIS 498493] [PubMed 12820816]
40. Koller EA, Weber J, Doraiswamy PM et al. A survey of reports of quetiapine-associated hyperglycemia and diabetes mellitus. J Clin Psychiatry. 2004; 65:857-63. [IDIS 518849] [PubMed 15291665]
41. Ananth J, Johnson KM, Levander EM et al. Diabetic ketoacidosis, neuroleptic malignant syndrome, and myocardial infarction in a patient taking risperidone and lithium carbonate. J Clin Psychiatry. 2004; 65:724. [IDIS 516345] [PubMed 15163265]
42. Torrey EF, Swalwell CI. Fatal olanzapine-induced ketoacidosis. Am J Psychiatry. 2003; 160:2241. [IDIS 516756] [PubMed 14638601]
43. Wehring HJ, Kelly DL, Love RC et al. Deaths from diabetic ketoacidosis after long-term clozapine treatment. Am J Psychiatry. 2003; 160:2241-2. [IDIS 516757] [PubMed 14638600]
44. Koro CE, Fedder DO, L’Italien GJ et al. Assessment of independent effect of olanzapine and risperidone on risk of diabetes among patients with schizophrenia: population based nested case-control study. BMJ. 2002; 325:243. [IDIS 485916] [PubMed 12153919]
45. Citrome LL. Efficacy should drive atypical antipsychotic treatment. BMJ. 2003; 326:283. [IDIS 492968] [PubMed 12561827]
46. Anon. Which atypical antipsychotic for schizophrenia?. Drug Ther Bull. 2004; 42:57-60. [PubMed 15310154]
47. Anon. Atypical antipsychotics and hyperglycaemia. Aust Adv Drug React Bull. 2004; 23:11-2.
48. Sussman N. The implications of weight changes with antipsychotic treatment. J Clin Psychopharmacol. 2003; 23 (Suppl 1):S21-6.
49. Gianfrancesco F, Grogg A, Mahmoud R et al. Differential effects of antipsychotic agents on the risk of development of type 2 diabetes mellitus in patients with mood disorders. Clin Ther. 2003; 25:1150-71. [IDIS 497269] [PubMed 12809963]
50. Bushe C, Leonard B. Association between atypical antipsychotic agents and type 2 diabetes: review of prospective clinical data. Br J Psychiatry Suppl. 2004; 47:S87-93. [PubMed 15056600]
51. Cavazzoni P, Mukhopadhyay N, Carlson C et al. Retrospective analysis of risk factors in patients with treatment-emergent diabetes during clinical trials of antipsychotic medications. Br J Psychiatry Suppl. 2004; 47:s94-101. [PubMed 15056601]
52. Gianfrancesco FD, Grogg AL, Mahmoud RA et al. Differential effects of risperidone, olanzapine, clozapine, and conventional antipsychotics on type 2 diabetes: findings from a large health plan database. J Clin Psychiatry. 2002; 63:920-30. [IDIS 488480] [PubMed 12416602]
53. Etminan M, Streiner DL, Rochon PA. Exploring the association between atypical neuroleptic agents and diabetes mellitus in older adults. Pharmacotherapy. 2003; 23:1411-15. [IDIS 510498] [PubMed 14620387]
54. Leslie DL, Rosenheck RA. Incidence of newly diagnosed diabetes attributable to atypical antipsychotic medications. Am J Psychiatry. 2004; 161:1709-11. [IDIS 522186] [PubMed 15337666]
55. Sernyak MJ, Leslie DL, Alarcon RD et al. Association of diabetes mellitus with use of atypical neuroleptics in the treatment of schizophrenia. Am J Psychiatry. 2002; 159:561-6. [IDIS 494206] [PubMed 11925293]
56. Geller WK, MacFadden W. Diabetes and atypical neuroleptics. Am J Psychiatry. 2003; 160:388. [IDIS 513919] [PubMed 12562601]
57. Gianfrancesco FD. Diabetes and atypical neuroleptics. Am J Psychiatry. 2003; 160:388-9; author reply 389. [IDIS 513920] [PubMed 12562599]
58. Lamberti JS, Crilly JF, Maharaj K. Prevalence of diabetes mellitus among outpatients with severe mental disorders receiving atypical antipsychotic drugs. J Clin Psychiatry. 2004; 65:702-6. [IDIS 516341] [PubMed 15163259]
59. Lee DW, Fowler RB. Olanzapine/risperidone and diabetes risk. J Clin Psychiatry. 2003; 64:847-8; author reply 848. [IDIS 500324] [PubMed 12934988]
60. Reviewer Comments (personal observations).
61. Bristol-Myers Squibb., Princeton, NJ: Personal communication.
62. AstraZeneca. Wayne, PA: Personal communication.
63. Eli Lilly and Company. Indianapolis, IN: Personal com
Generic Name: guaifenesin, phenylephrine, and pyrilamine (gwye FEN e sin, fen il EFF rin, and pir IL a meen)
Brand Names: A-Tan 12X, Ryna-12X
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
The combination of guaifenesin, phenylephrine, and pyrilamine is used to treat runny or stuffy nose, sinus congestion, sneezing, watery eyes, and cough caused by allergies, the common cold, or the flu.
Guaifenesin, phenylephrine, and pyrilamine may also be used for other purposes not listed in this medication guide.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
Before taking this medication, tell your doctor if you are allergic to any other drugs, or if you have:
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
glaucoma;
a peripheral vascular disorder (poor circulation);
kidney disease;
an enlarged prostate; or
problems with urination.
If you have any of these conditions, may need a dose adjustment or special tests to safely take this medication.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Some antihistamines can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking this medication.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
blurred vision;
dry mouth;
dizziness, drowsiness, headache;
problems with memory or concentration;
ringing in your ears;
restless or excitability (especially in children);
warmth, tingling, or redness under your skin;
sleep problems (insomnia);
skin rash or itching; or
mild nausea, stomach pain, constipation.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Before taking this medication, tell your doctor if you are using any of the following drugs:
an antidepressant;
a diuretic (water pill);
medicines to treat high blood pressure;
medication to treat irritable bowel syndrome;
seizure medication;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and there may be other drugs that can interact with guaifenesin, phenylephrine, and pyrilamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: A-Tan2X side effects (in more detail)
Balneum
Active substance: soya oil 84.75 %
Balneum is a bath additive that contains soya oil and is used for the treatment of dry skin disorders such as eczema and dermatitis.
Balneum relieves symptoms associated with dry skin whilst also cleansing, and helping to protect against further drying.
Soya oil is an emollient (moisturiser) which soothes and softens dry skin by helping to replace lost oils. The oil forms tiny droplets in the water which leave a thin film on your skin. This film helps to stop your skin from drying out and so makes it feel soft.
All full baths - including those to which Balneum has been added - should only be taken after consultation with your doctor in the following cases: major skin injuries, acute skin diseases of unknown cause, feverish and infectious diseases, heart failure and high blood pressure.
If the above applies to you, do not use this medicine and talk to your doctor.
There are no known interactions when using Balneum with other medicines but please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Ask your doctor or pharmacist for advice before taking any medicine.
You may use Balneum whilst you are pregnant.
Balneum is not expected to have any effect on your ability to drive or use machines.
Due to its propylene glycol content this medicine may cause skin irritation.
Balneum contains soya oil: If you are allergic to peanut or soya, do not use this medicinal product.
The perfume contains benzylbenzoate which may be mildly irritant to the skin, eyes and mucous membranes.
It also contains butylated hydroxytoluene which may cause local skin irritation (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Always use Balneum exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Measurements:
If you have very dry skin, you can use two or three times the above amounts.
Always clean the bath immediately after you have used Balneum. To do this, rinse the bath and equipment thoroghly with hot water and then clean with a household cleaner.
Your doctor will tell you for how long you need to use Balneum.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Balneum can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Balneum after the expiry date which is stated on the label and the carton after EXP.
The expiry date refers to the last day of that month.
You should store Balneum in its original pack.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
The active substance is soya oil 84.75%.
The other ingredients are polyoxyethylene lauryl ether, oleic acid, diethanolamide, perfume oil, propylene glycol, butylated hydroxytoluene, ascorbyl palmitate and citric acid monohydrate.
Balneum is an oily liquid.
Your medicinal product comes in either 20 ml, 95 ml, 100 ml, 150 ml, 200 ml, 225 ml, 250 ml, 300 ml, 500 ml, 2x500 ml, 600 ml, or 1000 ml high density polyethylene bottles with a screw cap and also in 10 ml and 20 ml foil laminate sachets and 20 ml polyethylene/foil blisters.
Not all pack sizes may be marketed.
This leaflet was last approved in: 01.07.2010
OTHER INFORMATION
Self Help Measures
Eczema and dermatitis have many different causes and there are various self help measures you can adopt.
If you want to find out more, you may find the following organisation helpful:
8000xxxx/ GB / 0410
kal-si-TOE-nin (SA-man)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Calcium Regulator
Pharmacologic Class: Calcitonin
Calcitonin injection is used to treat Paget's disease of the bone. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood).
calcitonin is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For calcitonin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to calcitonin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of calcitonin injection in the pediatric population. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of calcitonin injection in geriatric patients.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking calcitonin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using calcitonin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of calcitonin. Make sure you tell your doctor if you have any other medical problems, especially:
calcitonin is given as a shot under your skin or into one of your muscles. Calcitonin injection may be given at home to patients who do not need to be in the hospital. If you are using calcitonin at home, your doctor will teach you how to prepare and inject the medicine. Be sure you understand exactly how to use the medicine.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
Use a new needle and syringe each time you inject your medicine.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Carefully look at each vial (glass container) of medicine before you use it. Do not use the vial if it appears to be damaged or if the medicine has changed color or has specks (particles) in it.
The dose of calcitonin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of calcitonin. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of calcitonin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store in the refrigerator. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure that calcitonin is working properly. Blood and urine tests may be needed to check for unwanted effects.
calcitonin may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using calcitonin.
If you are using calcitonin for hypercalcemia (too much calcium in the blood), your doctor may want you to follow a low-calcium diet. If you have any questions about this, check with your doctor.
If you are using calcitonin for postmenopausal osteoporosis, your doctor may also want you to take calcium and vitamin D every day. If you have any questions about this, check with your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: calcitonin Injection side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
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.
Uterotonic agents increase the uterine tone and contractions. These agents intensify uterine muscle contractions at the beginning and during labor, and during the postpartum period. Oxytocin, a hormone produced by the posterior pituitary, is a natural uterotonic.
Uterotonic agents are used to induce labor and for elected abortions. They lessen blood loss during childbirth and are extremely important in the prevention and treatment of postpartum hemorrhage.
Medical conditions associated with uterotonic agents:
Solpadeine Plus Capsules
Each capsule contains Paracetamol Ph Eur. 500 mg, Codeine Phosphate Hemihydrate Ph Eur 8 mg and Caffeine Ph Eur 30.0 mg.
Capsule.
For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
Solpadeine Plus Capsules are recommended for the relief of migraine, headache, backache, rheumatic pain, period pains, dental pain, strains & sprains and sciatica.
Adults (including the elderly)
2 capsules up to four times daily. Maximum 8 capsules in 24 hours. The dose should not be repeated more frequently than every 4 hours. Do not take for more than 3 days without consulting a doctor. For oral administration only.
Children
The product is not recommended for children under 12 years of age.
Do not take for more than 3 days continuously without medical review.
Hypersensitivity to paracetamol, caffeine, codeine, opioid analgesics or any of the other constituents.
Use of codeine containing products is contraindicated in mothers who are breast feeding unless prescribed by a doctor.
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised not to take other paracetamol or codeine-containing products concurrently.
If symptoms persist, consult your doctor.
Keep out of the reach and sight of children.
Patients with obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product.
Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients.
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
The leaflet will state:
Headlines section (to be prominently displayed)
• This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked.
• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take this medicine for headaches for more than 3 days it can make them worse.
Section 1: What the medicine is for:
• Solpadeine Plus Capsules are for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, rheumatic pain and sciatica.
Section 2: Before taking
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take a painkiller for headaches for more than 3 days it can make them worse.
Section 3: Dosage
• Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist
• Possible withdrawal effects
This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
Section 4: Side effects
• Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.
• How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended dose
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
The label will state:
Front of pack
• Can cause addiction
• Use for 3 days only
Back of pack
• Solpadeine Plus Capsules are for the short term treatment of acute moderate pain when other painkillers have not worked. Wait at least four hours after taking any other painkiller before you take this medicine. For: migraine, headache, dental pain, period pain, backache, rheumatic pain, strains & sprains and sciatica.
• If you need to take this medicine continuously for more than 3 days you should see your doctor or pharmacist
• This medicine contains codeine which can cause addiction if you take continuously for more than 3 days. If you take this medicine for headaches for more than 3 days it can make them worse.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Opioid analgesics should be given with care to patients receiving monoamine oxidase inhibitors. The effect of CNS depressants (including alcohol) may be potentiated by codeine; these interactions are unlikely to be significant at the dosage involved.
Pregnancy
Use during pregnancy should be avoided, unless advised by a physician. This includes maternal use during labour because of the potential for respiratory depression in the neonate.
The safety of paracetamol-caffeine-codeine during pregnancy has not been established relative to the possible adverse effects of foetal development and should be avoided during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
Lactation
At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.
If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
Although significant caffeine toxicity has been observed in breastfed infants, caffeine may have a stimulating effect on the infant.
Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.
Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system. The frequency of these adverse events is not known (cannot be estimated from available data).
Paracetamol
|
|
|
|
|
|
|
|
|
|
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Caffeine
|
|
|
|
When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.
Codeine
Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class. The frequency of these reactions is not known.
|
|
|
|
|
|
|
|
|
|
Overuse of this product, defined as consumption of quantities in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency. Symptoms of restlessness and irritability may result when treatment is stopped.
Codeine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
An overdose of codeine is characterised, in the first phase, by nausea and vomiting. An acute depression of the respiratory centre can cause cyanosis, slower breathing, drowsiness, ataxia and, more rarely, pulmonary oedema. Respiratory pauses, miosis, convulsion, collapse and urine retention. Signs of histamine release have been observed as well.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg. Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
Paracetamol
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors:
If the patient
Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
Regularly consumes ethanol in excess of recommended amounts.
Or
Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Caffeine
Symptoms and signs
Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.
Management
Patients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose, but can be considered for up to four hours after the overdose. The CNS effects of overdose may be treated with intravenous sedatives.
Summary
Treatment of overdose with Solpadeine Plus Capsules requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of codeine and caffeine toxicity being managed symptomatically.
Paracetamol is an analgesic and antipyretic. Codeine phosphate is a moderate analgesic and has weak cough suppressant activity. Caffeine is a potent stimulator of the CNS.
Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost completely renal, in the form of conjugated metabolites.
Caffeine is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65-80% of administered caffeine is excreted in the urine as 1-methyluric acid 1-methylxanthine.
Codeine phosphate is well absorbed after oral administration and is widely distributed. About 86% is excreted in the urine in 24 hours; 40-70% is free or conjugated codeine, 5-15% is free or conjugated morphine and 10-20% is free or conjugated norcodeine.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Maize starch, magnesium stearate, titanium dioxide (E 171), erythrosine (E 127), patent blue V (E 131), quinoline yellow (E 104), gelatin. Printing Ink: shellac, propylene glycol and colour black iron oxide (E172).
None stated.
60 months.
Store below 25°C.
PVC 250 µm / aluminium foil 30 µm blister strips in a cardboard carton, containing 6, 12, 16, 24, and 32 capsules.
Not applicable.
SmithKline Beecham (SWG) Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as Sterling Health or GlaxoSmithKline Consumer Healthcare or SmithKline Beecham International, Brentford, TW8 9GS.
PL 00071/0186
09.05.83 / 21.04.95
21.06.2011
